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1. Early-Life Outcomes in Relation to Social Determinants of Health for Children Born Extremely Preterm

Author

Jane E. Brumbaugh, Betty R. Vohr, Edward F. Bell, Carla M. Bann, Colm P. Travers, Elisabeth C. McGowan, Heidi M. Harmon, Waldemar A. Carlo, Andrea F. Duncan, Susan R. Hintz, Alan H. Jobe, Michael S. Caplan, Richard A. Polin, Abbot R. Laptook, Martin Keszler, Angelita M. Hensman, Barbara Alksninis, Carmena Bishop, Robert T. Burke, Melinda Caskey, Laurie Hoffman, Katharine Johnson, Mary Lenore Keszler, Andrea M. Knoll, Vita Lamberson, Teresa M. Leach, Emilee Little, Bonnie E. Stephens, Elisa Vieira, Lucille St. Pierre, Suzy Ventura, Victoria E. Watson, Anna Maria Hibbs, Michele C. Walsh, Deanne E. Wilson-Costello, Nancy S. Newman, Monika Bhola, Allison H. Payne, Bonnie S. Siner, Gulgun Yalcinkaya, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Scott, Prabhu S. Parimi, Lisa Gaetano, Brenda B. Poindexter, Kurt Schibler, Suhas G. Kallapur, Edward F. Donovan, Stephanie Merhar, Cathy Grisby, Kimberly Yolton, Barbara Alexander, Traci Beiersdorfer, Kate Bridges, Tanya E. Cahill, Juanita Dudley, Estelle E. Fischer, Teresa L. Gratton, Devan Hayes, Jody Hessling, Lenora D. Jackson, Kristin Kirker, Holly L. Mincey, Greg Muthig, Sara Stacey, Jean J. Steichen, Stacey Tepe, Julia Thompson, Sandra Wuertz, C. Michael Cotten, Ronald N. Goldberg, Ricki F. Goldstein, William F. Malcolm, Deesha Mago-Shah, Patricia L. Ashley, Joanne Finkle, Kathy J. Auten, Kimberley A. Fisher, Sandra Grimes, Kathryn E. Gustafson, Melody B. Lohmeyer, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Gennie Bose, Cindy Clark, Jennifer Talbert, Diane Warner, Andrea Trembath, T. Michael O'Shea, Janice Wereszczak, Stephen D. Kicklighter, Ginger Rhodes-Ryan, Donna White, Ravi M. Patel, David P. Carlton, Barbara J. Stoll, Ellen C. Hale, Yvonne C. Loggins, Ira Adams-Chapman, Ann Blackwelder, Diane I. Bottcher, Sheena L. Carter, Salathiel Kendrick-Allwood, Judith Laursen, Maureen Mulligan LaRossa, Colleen Mackie, Amy Sanders, Irma Seabrook, Gloria Smikle, Lynn C. Wineski, Rosemary D. Higgins, Andrew A. Bremer, Stephanie Wilson Archer, Gregory M. Sokol, Anna M. Dusick, Lu Ann Papile, Susan Gunn, Faithe Hamer, Dianne E. Herron, Abbey C. Hines, Carolyn Lytle, Lucy C. Miller, Heike M. Minnich, Leslie Richard, Lucy Smiley, Leslie Dawn Wilson, Jon E. Tyson, Kathleen A. Kennedy, Amir M. Khan, Andrea Duncan, Ricardo Mosquera, Emily K. Stephens, Georgia E. McDavid, Nora I. Alaniz, Elizabeth Allain, Julie Arldt-McAlister, Katrina Burson, Allison G. Dempsey, Elizabeth Eason, Patricia W. Evans, Carmen Garcia, Charles Green, Donna Hall, Beverly Foley Harris, Margarita Jiminez, Janice John, Patrick M. Jones, M. Layne Lillie, Anna E. Lis, Karen Martin, Sara C. Martin, Carrie M. Mason, Shannon McKee, Brenda H. Morris, Kimberly Rennie, Shawna Rodgers, Saba Khan Siddiki, Maegan C. Simmons, Daniel Sperry, Patti L. Pierce Tate, Sharon L. Wright, Pablo J. Sánchez, Leif D. Nelin, Sudarshan R. Jadcherla, Jonathan L. Slaughter, Keith O. Yeates, Sarah Keim, Nathalie L. Maitre, Christopher J. Timan, Patricia Luzader, Erna Clark, Christine A. Fortney, Julie Gutentag, Courtney Park, Julie Shadd, Margaret Sullivan, Melanie Stein, Mary Ann Nelin, Julia Newton, Kristi Small, Stephanie Burkhardt, Jessica Purnell, Lindsay Pietruszewski, Katelyn Levengood, Nancy Batterson, Pamela Morehead, Helen Carey, Lina Yoseff-Salameh, Rox Ann Sullivan, Cole Hague, Jennifer Grothause, Erin Fearns, Aubrey Fowler, Jennifer Notestine, Jill Tonneman, Krystal Hay, Michelle Chao, Kyrstin Warnimont, Laura Marzec, Bethany Miller, Demi R. Beckford, Hallie Baugher, Brittany DeSantis, Cory Hanlon, Jacqueline McCool, Abhik Das, Marie G. Gantz, Dennis Wallace, Margaret M. Crawford, Jenna Gabrio, David Leblond, Jamie E. Newman, Carolyn M. Petrie Huitema, Jeanette O'Donnell Auman, W. Kenneth Poole, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, Valerie Y. Chock, David K. Stevenson, Marian M. Adams, M. Bethany Ball, Barbara Bentley, Elizabeth Bruno, Alexis S. Davis, Maria Elena DeAnda, Anne M. DeBattista, Lynne C. Huffman, Magdy Ismael, Jean G. Kohn, Casey Krueger, Janice Lowe, Ryan E. Lucash, Andrew W. Palmquist, Jessica Patel, Melinda S. Proud, Elizabeth N. Reichert, Nicholas H. St. John, Dharshi Sivakumar, Heather L. Taylor, Natalie Wager, R. Jordan Williams, Hali Weiss, Ivan D. Frantz, John M. Fiascone, Brenda L. MacKinnon, Anne Furey, Ellen Nylen, Paige T. Church, Cecelia E. Sibley, Ana K. Brussa, Namasivayam Ambalavanan, Myriam Peralta-Carcelen, Kathleen G. Nelson, Kirstin J. Bailey, Fred J. Biasini, Stephanie A. Chopko, Monica V. Collins, Shirley S. Cosby, Kristen C. Johnston, Mary Beth Moses, Cryshelle S. Patterson, Vivien A. Phillips, Julie Preskitt, Richard V. Rector, Sally Whitley, Uday Devaskar, Meena Garg, Isabell B. Purdy, Teresa Chanlaw, Rachel Geller, Neil N. Finer, Yvonne E. Vaucher, David Kaegi, Maynard R. Rasmussen, Kathy Arnell, Clarence Demetrio, Martha G. Fuller, Wade Rich, Tarah T. Colaizy, John A. Widness, Michael J. Acarregui, Karen J. Johnson, Diane L. Eastman, Claire A. Goeke, Mendi L. Schmelzel, Jacky R. Walker, Michelle L. Baack, Laurie A. Hogden, Megan Broadbent, Chelsey Elenkiwich, Megan M. Henning, Sarah Van Muyden, Dan L. Ellsbury, Donia B. Campbell, Tracy L. Tud, Shahnaz Duara, Charles R. Bauer, Ruth Everett-Thomas, Sylvia Fajardo-Hiriart, Arielle Rigaud, Maria Calejo, Silvia M. Frade Eguaras, Michelle Harwood Berkowits, Andrea Garcia, Helina Pierre, Alexandra Stoerger, Kristi L. Watterberg, Janell Fuller, Robin K. Ohls, Sandra Sundquist Beauman, Conra Backstrom Lacy, Mary Hanson, Carol Hartenberger, Elizabeth Kuan, Jean R. Lowe, Rebecca A. Thomson, Sara B. DeMauro, Eric C. Eichenwald, Barbara Schmidt, Haresh Kirpalani, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Christine Catts, Noah Cook, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Sarvin Ghavam, Hallam Hurt, Jonathan Snyder, Saritha Vangala, Kristina Ziolkowski, Carl T. D'Angio, Dale L. Phelps, Ronnie Guillet, Gary J. Myers, Michelle Andrews-Hartley, Julie Babish Johnson, Kyle Binion, Melissa Bowman, Elizabeth Boylin, Erica Burnell, Kelly R. Coleman, Cait Fallone, Osman Farooq, Julianne Hunn, Diane Hust, Rosemary L. Jensen, Rachel Jones, Jennifer Kachelmeyer, Emily Kushner, Deanna Maffett, Kimberly G. McKee, Joan Merzbach, Constance Orme, Diane Prinzing, Linda J. Reubens, Daisy Rochez, Mary Rowan, Premini Sabaratnam, Ann Marie Scorsone, Holly I.M. Wadkins, Kelley Yost, Lauren Zwetsch, Satyan Lakshminrusimha, Anne Marie Reynolds, Michael G. Sacilowski, Stephanie Guilford, Emily Li, Ashley Williams, William A. Zorn, Myra H. Wyckoff, Luc P. Brion, Walid A. Salhab, Charles R. Rosenfeld, Roy J. Heyne, Diana M. Vasil, Sally S. Adams, Lijun Chen, Maria M. De Leon, Francis Eubanks, Alicia Guzman, Gaynelle Hensley, Elizabeth T. Heyne, Lizette E. Lee, Melissa H. Leps, Linda A. Madden, E. Rebecca McDougald, Nancy A. Miller, Janet S. Morgan, Lara Pavageau, Pollieanna Sepulveda, Kristine Tolentino-Plata, Cathy Twell Boatman, Azucena Vera, Jillian Waterbury, Bradley A. Yoder, Mariana Baserga, Roger G. Faix, Sarah Winter, Stephen D. Minton, Mark J. Sheffield, Carrie A. Rau, Shawna Baker, Karie Bird, Jill Burnett, Susan Christensen, Laura Cole-Bledsoe, Brandy Davis, Jennifer O. Elmont, Jennifer J. Jensen, Manndi C. Loertscher, Jamie Jordan, Trisha Marchant, Earl Maxson, Kandace M. McGrath, Karen A. Osborne, D. Melody Parry, Brixen A. Reich, Susan T. Schaefer, Cynthia Spencer, Michael Steffen, Katherine Tice, Kimberlee Weaver-Lewis, Kathryn D. Woodbury, Karen Zanetti, Robert G. Dillard, Lisa K. Washburn, Barbara G. Jackson, Nancy Peters, Korinne Chiu, Deborah Evans Allred, Donald J. Goldstein, Raquel Halfond, Carroll Peterson, Ellen L. Waldrep, Cherrie D. Welch, Melissa Whalen Morris, Gail Wiley Hounshell, Seetha Shankaran, Beena G. Sood, Girija Natarajan, Athina Pappas, Katherine Abramczyk, Prashant Agarwal, Monika Bajaj, Rebecca Bara, Elizabeth Billian, Sanjay Chawla, Kirsten Childs, Lilia C. De Jesus, Debra Driscoll, Melissa February, Laura A. Goldston, Mary E. Johnson, Geraldine Muran, Bogdan Panaitescu, Jeannette E. Prentiss, Diane White, Eunice Woldt, John Barks, Stephanie A. Wiggins, Mary K. Christensen, Martha D. Carlson, Richard A. Ehrenkranz, Harris Jacobs, Christine G. Butler, Patricia Cervone, Sheila Greisman, Monica Konstantino, JoAnn Poulsen, Janet Taft, Joanne Williams, and Elaine Romano

Subjects
Pediatrics, Perinatology and Child Health
Published
2023

2. Growth Rates of Infants Randomized to Continuous Positive Airway Pressure or Intubation After Extremely Preterm Birth

Author

Jean R. Lowe, Yvonne E. Vaucher, Ira Adams-Chapman, Elizabeth F. Bruno, Paul Zlotnik, Kristin M. Zaterka-Baxter, Nancy Close, Alicia Guzman, Susan R. Hintz, Amanda Soong, Wade Rich, Alexandra Stroerger, Seetha Shankaran, Saba Siddiki, Sharon L. Wright, Kimberlee Weaver-Lewis, Gary David Markowitz, Linda Black, Anne M. DeBattista, Donald J. Goldstein, Monika Bhola, Marcia Worley Mersmann, Brenda H. Morris, Vivek Narendran, Patricia L. Ashley, Theresa M. Leach, Barbara J. Stoll, Gail Hounshell, Kim Francis, M. Bethany Ball, Laura A. Goldston, Michele C. Walsh, Amy K. Hutchinson, Tarah T. Colaizy, David K. Stevenson, Lisa K. Washburn, Meghan Lukasik, Abhik Das, Linda J. Reubens, Maureen Mulligan LaRossa, Rene Barbieri-Welge, John M. Fiascone, Ann B. Cook, Jon E. Tyson, Carlos Torres, Renee Bridge, Melinda S. Proud, John A. Widness, Stephanie Wilson Archer, Kathleen G. Nelson, Kristi L. Watterberg, Katherine A. Foy, Abbot R. Laptook, Dan Gingras, Bradley A. Yoder, Michelle Harwood Berkowits, Richard A. Ehrenkranz, Janet Taft, Neil N. Finer, Fred J. Biasini, J. M. DiFiore, James P. Kiley, Anthony J. Piazza, Shahnaz Duara, William F. Malcolm, Lizette E. Torres, Kathy J. Auten, Dianne E. Herron, Mike Steffens, Nancy Peters, Sally Whitley, Nancy S. Newman, Charles R. Rosenfeld, Nancy A. Miller, Sarah Martin, Beverly Foley Harris, Conra Backstrom Lacy, Linda A. Madden, Gloria V. Smikle, Kathy Arnell, Kristen C. Johnston, Anna M. Dusick, Martha G. Fuller, Heike M. Minnich, Vineet Bhandari, Donna Posin, Kate Bridges, Martha R. Leonard, Roy J. Heyne, Noelle Younge, Christine G. Butler, Patricia Gettner, Carolyn M. Petrie Huitema, Sharon F. Freedman, Rachel V. Walden, Helina Pierre, Waldemar A. Carlo, Robert G. Dillard, Joanne Williams, Ellen Nylen, Margarita Jiminez, Victoria E. Watson, Sheena L. Carter, Richard V. Rector, Barbara Alksninis, David Wang, Bill Cashore, Kimberley A. Fisher, Susie Buchter, Michael J. Acarregui, Bonnie E. Stephens, Alexis N. Diaz, W. Kenneth Poole, Ana K. Brussa, Alexis S. Davis, Carolyn Lytle, Jill Burnett, Laura Grau, Bonnie S. Siner, Melissa Whalen Morris, Karen A. Osborne, Melinda Caskey, Cryshelle S. Patterson, Renee P. Pyle, Laura L. Whitely, Harriet Friedman, Sheree York, Kelley Yost, Emily Kushner, Rebecca Bara, Cathy Grisby, Arlene Zadell, Barbara D. Alexander, Ivan D. Frantz, Myriam Peralta-Carcelen, James W. Pickett, Karen J. Johnson, Sheila Greisman, Susan Barnett, Beena G. Sood, Ann M. Blackwelder, Catherine Twell Boatman, Gary J. Myers, Athina Pappas, Ariel A. Salas, Jean G. Kohn, Ayala Ben-Tall, Ellen C. Hale, Brenda B. Poindexter, Rosemary D. Higgins, Elisabeth Dinkins, Elizabeth T. Heyne, Teresa L. Gratton, Kerry Wilder, Jonathan W. Mink, Regina A. Gargus, Deanne E. Wilson-Costello, Rebecca Montman, Charles R. Bauer, Dale L. Phelps, Jamie E. Newman, Leslie Dawn Wilson, Pablo J. Sánchez, Alan H. Jobe, Monica Konstantino, Melody B. Lohmeyer, Monica V. Collins, Charles Green, Hali E. Weiss, Elizabeth Billian, Dorothy B. Gail, Clarence Demetrio, Kurt Schibler, Mary Anne Berberich, Leslie Rodriguez, David K. Wallace, Shabnam Lainwala, Betty R. Vohr, Sobha Fritz, Kasey Hamlin-Smith, William Oh, Deborah Pontillo, David P. Carlton, Cheryl Runyan, Arielle Riguard, Shawna Baker, Avroy A. Fanaroff, Sara Krzywanski, Shirley S. Cosby, Barbara Bentley, Gaynelle Hensley, Walid A. Salhab, Joan Merzbach, Cecelia E. Sibley, James Allen, Elaine Romano, C. Michael Cotten, Maria Hopkins, Vivien Phillips, Kimberly Yolton, Michael S. Caplan, Kathryn E. Gustafson, Andrea Milena Becerra Garcia, Kirstin J. Bailey, Margaret L. Poundstone, Diana M. Vasil, Cherrie D. Welch, Sarah Lillie, Ellen Waldrep, Jeanette O'Donnell Auman, Gulgun Yalcinkaya, Kalida Mehta, Patricia W. Evans, Harris Gelbard, Carroll Peterson, Angelita M. Hensman, Sylvia Hiriart-Fajardo, Edward F. Donovan, Barbara Do, James Wilkes, Marie G. Gantz, Nicholas H. St. John, Elaine O. Mathews, Harris C. Jacobs, Deborah Evans Allred, Rosemary L. Jensen, Suzy Ventura, Kathleen A. Kennedy, Dawn Andrews, Walter Gilliam, Kristen Angela, Mary Johnson, Katharine Johnson, Krisa P. Van Meurs, Barbara G. Jackson, Betty K. Hastings, Holly L. Mincey, Elisabeth C. McGowan, Brenda L. MacKinnon, JoAnn Poulsen, Pat Cervone, Edward F. Bell, T. Michael O'Shea, Janet S. Morgan, Elaine Ito, Julie Rohr, Ruth Everett-Thomas, Patti L. Pierce Tate, Laura Cole, Maria Calejo, Dennis Wallace, Paul Wozniak, Maynard Rasmussen, Robin K. Ohls, Lisa Augostino, Silvia M. Frade Eguaras, Faithe Hamer, Julie Babish Johnson, Karen Zanetti, Roger G. Faix, Maria Elena DeAnda, Ronald N. Goldberg, James A. Lemons, Diane Hust, Stacy Reddoch, Karie Bird, Jody Hessling, Araceli Solis, Carol J. Blaisdell, Raquel Halfond, Erica Burnell, Nirupama Laroia, Georgia E. McDavid, Namasivayam Ambalavanan, Sally S. Adams, Korinne Chiu, Cynthia Spencer, Lucy Noel, Melissa Martin, Nora I. Alaniz, James R. Moore, Ricki F. Goldstein, Janell Fuller, Melissa H. Lepps, Anne Furey, Diane L. Eastman, Jonathan M. Klein, and Anna E. Lis

Subjects
Male, Pediatrics, medicine.medical_specialty, Birth weight, medicine.medical_treatment, Gestational Age, Lower risk, Article, Child Development, Positive airway pressure, Intubation, Intratracheal, medicine, Humans, Intubation, Oximetry, Continuous positive airway pressure, Respiratory Distress Syndrome, Newborn, Continuous Positive Airway Pressure, business.industry, Infant, Newborn, Postmenstrual Age, Gestational age, Pulmonary Surfactants, Neurodevelopmental Disorders, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Gestation, Female, Energy Intake, business
Abstract

OBJECTIVE: To evaluate the effects of early treatment with CPAP on nutritional intake and in-hospital growth rates of extremely preterm (EPT) infants. STUDY DESIGN: EPT infants (24–0/7 to 27–6/7 weeks of gestation) enrolled in the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) were included. EPT infants who died before 36 weeks’ postmenstrual age (PMA) were excluded. The growth rates from birth to 36 weeks’ PMA and follow-up outcomes at 18–22 months’ corrected age of EPT infants randomized at birth to either early CPAP (intervention group) or early intubation for surfactant administration (control group) were analyzed. RESULTS: 810 of 1316 infants enrolled in SUPPORT (414 in intervention group, 396 in control group) had growth data analyzed. Median gestational age was 26 weeks and mean birthweight was 839 grams. Baseline characteristics, total nutritional intake, and in-hospital comorbidities were not significantly different between groups. In a regression model, growth rates between birth and 36 weeks’ PMA as well as growth rates during multiple intervals from birth to day 7, day 7 to14, day 14 to 21, day 21 to 28, day 28 to 32 weeks’ PMA, and 32 weeks’ PMA to 36 weeks’ PMA did not differ between treatment groups. Independent of treatment group, higher growth rates from day 21 to day 28 were associated with a lower risk of Bayley III cognitive score

Published
2021

3. Developmental Outcomes of Extremely Preterm Infants with a Need for Child Protective Services Supervision

Author

Elisabeth C. McGowan, Abbot. R. Laptook, Jean Lowe, Myriam Peralta-Carcelen, Dhuly Chowdhury, Rosemary D. Higgins, Susan R. Hintz, Betty R. Vohr, Richard A. Polin, Abbott R. Laptook, Martin Keszler, Angelita M. Hensman, Barbara Alksninis, Kristin M. Basso, Robert Burke, Melinda Caskey, Katharine Johnson, Mary Lenore Keszler, Andrea M. Knoll, Theresa M. Leach, Emilee Little, Elisa Vieira, Victoria E. Watson, Suzy Ventura, Michele C. Walsh, Avroy A. Fanaroff, Anna Marie Hibbs, Deanne E. Wilson-Costello, Nancy S. Newman, Allison H. Payne, Bonnie S. Siner, Monika Bhola, Gulgun Yalcinkaya, Harriet G. Friedman, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Knutson, Kurt Schibler, Edward F. Donovan, Cathy Grisby, Kate Bridges, Barbara Alexander, Estelle E. Fischer, Holly L. Mincey, Jody Hessling, Teresa L. Gratton, Lenora Jackson, Kristin Kirker, Greg Muthig, Jean J. Steichen, Stacey Tepe, Kimberly Yolton, Ronald N. Goldberg, C. Michael Cotten, Ricki F. Goldstein, Patricia L. Ashley, William F. Malcolm, Kathy J. Auten, Kimberley A. Fisher, Sandra Grimes, Kathryn E. Gustafson, Melody B. Lohmeyer, Joanne Finkle, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Gennie Bose, Cindy Clark, Linda Manor, Diane Warner, Janice Wereszczak, David P. Carlton, Barbara J. Stoll, Ira Adams-Chapman, Ellen C. Hale, Yvonne Loggins, Stephanie Wilson Archer, Gregory M. Sokol, Brenda B. Poindexter, Anna M. Dusick, Lu-Ann Papile, Susan Gunn, Faithe Hamer, Dianne E. Herron, Abbey C. Hines, Carolyn Lytle, Heike M. Minnich, Lucy Smiley, Leslie Dawn Wilson, Pablo J. Sanchez, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Christine A. Fortney, Gail E. Besner, Nehal A. Parikh, Abhik Das, Dennis Wallace, Marie G. Gantz, W. Kenneth Poole, Jamie E. Newman, Jeanette O'Donnell Auman, Margaret M. Crawford, Carolyn M. Petrie Huitema, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, Alexis S. Davis, Andrew W. Palmquist, Melinda S. Proud, Barbara Bentley, Elizabeth Bruno, Maria Elena DeAnda, Anne M. DeBattista, Beth Earhart, Lynne C. Huffman, Jean G. Kohn, Casey Krueger, Hali E. Weiss, Ivan D. Frantz, John M. Fiascone, Brenda L. MacKinnon, Anne Furey, Ellen Nylen, Waldemar A. Carlo, Namasivayam Ambalavanan, Monica V. Collins, Shirley S. Cosby, Fred J. Biasini, Kristen C. Johnston, Kathleen G. Nelson, Cryshelle S. Patterson, Vivien A. Phillips, Sally Whitley, Uday Devaskar, Meena Garg, Isabell B. Purdy, Teresa Chanlaw, Rachel Geller, Neil N. Finer, Yvonne E. Vaucher, David Kaegi, Maynard R. Rasmussen, Kathy Arnell, Clarence Demetrio, Martha G. Fuller, Wade Rich, Edward F. Bell, Tarah T. Colaizy, Michael J. Acarregui, Dan L. Ellsbury, John A. Widness, Karen J. Johnson, Donia B. Campbell, Diane L. Eastman, Jacky R. Walker, Jane E. Brumbaugh, Shahnaz Duara, Charles R. Bauer, Ruth Everett-Thomas, Sylvia Fajardo-Hiriart, Arielle Rigaud, Maria Calejo, Silvia M. Frade Eguaras, Michelle Harwood Berkowits, Andrea Garcia, Helina Pierre, Alexandra Stoerger, Kristi L. Watterberg, Jean R. Lowe, Janell F. Fuller, Robin K. Ohls, Conra Backstrom Lacy, Andrea F. Duncan, Rebecca Montman, Barbara Schmidt, Haresh Kirpalani, Sara B. DeMauro, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Hallam Hurt, Carl T. D'Angio, Dale L. Phelps, Ronnie Guillet, Satyan Lakshminrusimha, Julie Babish Johnson, Linda J. Reubens, Cassandra A. Horihan, Diane Hust, Rosemary L. Jensen, Emily Kushner, Joan Merzbach, Gary J. Myers, Mary Rowan, Holly I.M. Wadkins, Melissa Bowman, Julianne Hunn, Stephanie Guilford, Deanna Maffett, Farooq Osman, Diane Prinzing, Anne Marie Reynolds, Michael G. Sacilowski, Ashley Williams, Karen Wynn, Kelley Yost, William Zorn, Lauren Zwetsch, Kathleen A. Kennedy, Jon E. Tyson, Georgia E. McDavid, Nora I. Alaniz, Julie Arldt-McAlister, Katrina Burson, Patricia W. Evans, Carmen Garcia, Charles Green, Beverly Foley Harris, Margarita Jiminez, Janice John, Patrick M. Jones, Layne M. Lillie, Anna E. Lis, Karen Martin, Sara C. Martin, Brenda H. Morris, M. Layne Poundstone, Peggy Robichaux, Shawna Rodgers, Saba Siddiki, Maegan C. Simmons, Daniel Sperry, Patti L. Pierce Tate, Sharon L. Wright, Myra H. Wyckoff, Luc P. Brion, Roy J. Heyne, Walid A. Salhab, Charles R. Rosenfeld, Diana M. Vasil, Lijun Chen, Alicia Guzman, Gaynelle Hensley, Melissa H. Leps, Nancy A. Miller, Janet S. Morgan, Sally S. Adams, Catherine Twell Boatman, Elizabeth T. Heyne, Linda A. Madden, Lizette E. Torres, Roger G. Faix, Bradley A. Yoder, Karen A. Osborne, Cynthia Spencer, Kimberlee Weaver-Lewis, Shawna Baker, Karie Bird, Jill Burnett, Michael Steffen, Jennifer J. Jensen, Sarah Winter, Karen Zanetti, T. Michael O'Shea, Robert G. Dillard, Lisa K. Washburn, Barbara G. Jackson, Nancy Peters, Korinne Chiu, Deborah Evans Allred, Donald J. Goldstein, Raquel Halfond, Carroll Peterson, Ellen L. Waldrep, Cherrie D. Welch, Melissa Whalen Morris, Gail Wiley Hounshell, Seetha Shankaran, Athina Pappas, John Barks, Rebecca Bara, Laura A. Goldston, Girija Natarajan, Mary Christensen, Stephanie A. Wiggins, Diane White, Richard A. Ehrenkranz, Harris Jacobs, Christine G. Butler, Patricia Cervone, Sheila Greisman, Monica Konstantino, JoAnn Poulsen, Janet Taft, Joanne Williams, and Elaine Romano

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Time Factors, Birth weight, Gestational Age, Prenatal care, Article, 03 medical and health sciences, 0302 clinical medicine, Child Development, stomatognathic system, Pregnancy, 030225 pediatrics, medicine, Hospital discharge, Humans, 030212 general & internal medicine, School education, Retrospective Studies, business.industry, Extremely preterm, Child Protective Services, Infant, Newborn, Infant, Cognition, Prenatal Care, Patient Discharge, United States, stomatognathic diseases, Foster care, Increased risk, Child, Preschool, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Female, business, Follow-Up Studies
Abstract

OBJECTIVE: To evaluate neurodevelopmental outcomes of preterm infants with need for Child Protective Services (CPS) supervision at hospital discharge compared with those discharged without CPS supervision. STUDY DESIGN: For infants born at

Published
2019

4. Behavior Profiles at 2 Years for Children Born Extremely Preterm with Bronchopulmonary Dysplasia

Author

Jane E. Brumbaugh, Edward F. Bell, Scott F. Grey, Sara B. DeMauro, Betty R. Vohr, Heidi M. Harmon, Carla M. Bann, Matthew A. Rysavy, J. Wells Logan, Tarah T. Colaizy, Myriam A. Peralta-Carcelen, Elisabeth C. McGowan, Andrea F. Duncan, Barbara J. Stoll, Abhik Das, Susan R. Hintz, Michael S. Caplan, Richard A. Polin, Abbot R. Laptook, Martin Keszler, Angelita M. Hensman, Elisa Vieira, Emilee Little, Robert T. Burke, Bonnie E. Stephens, Barbara Alksninis, Carmena Bishop, Mary L. Keszler, Teresa M. Leach, Victoria E. Watson, Andrea M. Knoll, Michele C. Walsh, Avroy A. Fanaroff, Nancy S. Newman, Deanne E. Wilson-Costello, Allison Payne, Monika Bhola, Gulgun Yalcinkaya, Bonnie S. Siner, Harriet G. Friedman, Elizabeth Roth, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Knutson, Kurt Schibler, Brenda B. Poindexter, Stephanie Merhar, Kimberly Yolton, Teresa L. Gratton, Cathy Grisby, Kristin Kirker, Sandra Wuertz, David P. Carlton, Ira Adams-Chapman, Ellen C. Hale, Yvonne C. Loggins, Diane I. Bottcher, Colleen Mackie, Sheena L. Carter, Maureen Mulligan LaRossa, Lynn C. Wineski, Gloria V. Smikle, Angela Leon-Hernandez, Salathiel Kendrick-Allwood, C. Michael Cotten, Ronald N. Goldberg, Ricki F. Goldstein, William F. Malcolm, Patricia L. Ashley, Joanne Finkle, Kimberley A. Fisher, Sandra Grimes, Kathryn E. Gustafson, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Gennie Bose, Diane Warner, Janice Wereszczak, Stephen D. Kicklighter, Ginger Rhodes-Ryan, Rosemary D. Higgins, Stephanie Wilson Archer, Gregory M. Sokol, Lu Ann Papile, Abbey C. Hines, Dianne E. Herron, Susan Gunn, Lucy Smiley, Kathleen A. Kennedy, Jon E. Tyson, Julie Arldt-McAlister, Katrina Burson, Allison G. Dempsey, Patricia W. Evans, Carmen Garcia, Margarita Jiminez, Janice John, Patrick M. Jones, M. Layne Lillie, Karen Martin, Sara C. Martin, Georgia E. McDavid, Shawna Rodgers, Saba Khan Siddiki, Daniel Sperry, Patti L. Pierce Tate, Sharon L. Wright, Pablo J. Sánchez, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Christine A. Fortney, Gail E. Besner, Nehal A. Parikh, Dennis Wallace, Marie G. Gantz, Jamie E. Newman, Jeanette O'Donnell Auman, Margaret Crawford, Jenna Gabrio, David Leblond, Carolyn M. Petrie Huitema, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, Valerie Y. Chock, David K. Stevenson, Marian M. Adams, M. Bethany Ball, Barbara Bentley, Maria Elena DeAnda, Anne M. Debattista, Beth Earhart, Lynne C. Huffman, Magdy Ismael, Casey E. Krueger, Andrew W. Palmquist, Melinda S. Proud, Elizabeth N. Reichert, Meera N. Sankar, Nicholas H. St. John, Heather L. Taylor, Hali E. Weiss, Ivan D. Frantz, John M. Fiascone, Brenda L. MacKinnon, Ellen Nylen, Anne Furey, Cecelia E. Sibley, Ana K. Brussa, Waldemar A. Carlo, Namasivayam Ambalavanan, Kirstin J. Bailey, Fred J. Biasini, Monica V. Collins, Shirley S. Cosby, Vivien A. Phillips, Richard V. Rector, Sally Whitley, Uday Devaskar, Meena Garg, Isabell B. Purdy, Teresa Chanlaw, Rachel Geller, Neil N. Finer, Yvonne E. Vaucher, David Kaegi, Maynard R. Rasmussen, Kathy Arnell, Clarence Demetrio, Martha G. Fuller, Wade Rich, Radmila West, Michelle L. Baack, Dan L. Ellsbury, Laurie A. Hogden, Jonathan M. Klein, John M. Dagle, Karen J. Johnson, Tracy L. Tud, Chelsey Elenkiwich, Megan M. Henning, Megan Broadbent, Mendi L. Schmelzel, Jacky R. Walker, Claire A. Goeke, Kristi L. Watterberg, Robin K. Ohls, Conra Backstrom Lacy, Sandra Brown, Janell Fuller, Carol Hartenberger, Jean R. Lowe, Sandra Sundquist Beauman, Mary Ruffner Hanson, Tara Dupont, Elizabeth Kuan, Barbara Schmidt, Haresh Kirpalani, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Hallam Hurt, Carl T. D'Angio, Ronnie Guillet, Gary J. Myers, Satyan Lakshminrusimha, Anne Marie Reynolds, Michelle E. Hartley-McAndrew, Holly I.M. Wadkins, Michael G. Sacilowski, Linda J. Reubens, Rosemary L. Jensen, Joan Merzbach, William Zorn, Osman Farooq, Deanna Maffett, Ashley Williams, Julianne Hunn, Stephanie Guilford, Kelley Yost, Mary Rowan, Diane M. Prinzing, Karen Wynn, Cait Fallone, Ann Marie Scorsone, Myra H. Wyckoff, Luc P. Brion, Roy J. Heyne, Diana M. Vasil, Sally S. Adams, Lijun Chen, Maria M. De Leon, Frances Eubanks, Alicia Guzman, Elizabeth T. Heyne, Linda A. Madden, Nancy A. Miller, Lizette E. Lee, Lara Pavageau, Pollieanna Sepulveda, Cathy Twell Boatman, Roger G. Faix, Bradley A. Yoder, Mariana Baserga, Karen A. Osborne, Shawna Baker, Karie Bird, Jill Burnett, Susan Christensen, Brandy Davis, Jennifer O. Elmont, Jennifer J. Jensen, Manndi C. Loertscher, Trisha Marchant, Earl Maxson, Stephen D. Minton, D. Melody Parry, Carrie A. Rau, Susan T. Schaefer, Mark J. Sheffield, Cynthia Spencer, Mike Steffen, Kimberlee Weaver-Lewis, Sarah Winter, Kathryn D. Woodbury, Karen Zanetti, Seetha Shankaran, Sanjay Chawla, Beena G. Sood, Athina Pappas, Girija Natarajan, Monika Bajaj, Rebecca Bara, Mary E. Johnson, Laura Goldston, Stephanie A. Wiggins, Mary K. Christensen, Martha Carlson, John Barks, Diane F. White, Richard A. Ehrenkranz, Harris Jacobs, Christine G. Butler, Patricia Cervone, Sheila Greisman, Monica Konstantino, JoAnn Poulsen, Janet Taft, and Elaine Romano

Subjects
Male, Pediatrics, medicine.medical_specialty, CBCL, behavioral disciplines and activities, Language Development, Severity of Illness Index, 03 medical and health sciences, 0302 clinical medicine, Cognition, 030225 pediatrics, mental disorders, Medicine, Humans, 030212 general & internal medicine, Prospective Studies, Child Behavior Checklist, Motor skill, Bronchopulmonary Dysplasia, Problem Behavior, business.industry, Confounding, Postmenstrual Age, Infant, Newborn, medicine.disease, Bronchopulmonary dysplasia, Motor Skills, Child, Preschool, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Infant Behavior, Gestation, Female, business
Abstract

To characterize behavior of 2-year-old children based on the severity of bronchopulmonary dysplasia (BPD).We studied children born at 22-26 weeks of gestation and assessed at 22-26 months of corrected age with the Child Behavior Checklist (CBCL). BPD was classified by the level of respiratory support at 36 weeks of postmenstrual age. CBCL syndrome scales were the primary outcomes. The relationship between BPD grade and behavior was evaluated, adjusting for perinatal confounders. Mediation analysis was performed to evaluate whether cognitive, language, or motor skills mediated the effect of BPD grade on behavior.Of 2310 children, 1208 (52%) had no BPD, 806 (35%) had grade 1 BPD, 177 (8%) had grade 2 BPD, and 119 (5%) had grade 3 BPD. Withdrawn behavior (P .001) and pervasive developmental problems (P .001) increased with worsening BPD grade. Sleep problems (P = .008) and aggressive behavior (P = .023) decreased with worsening BPD grade. Children with grade 3 BPD scored 2 points worse for withdrawn behavior and pervasive developmental problems and 2 points better for externalizing problems, sleep problems, and aggressive behavior than children without BPD. Cognitive, language, and motor skills mediated the effect of BPD grade on the attention problems, emotionally reactive, somatic complaints, and withdrawn CBCL syndrome scales (P values .05).BPD grade was associated with increased risk of withdrawn behavior and pervasive developmental problems but with decreased risk of sleep problems and aggressive behavior. The relationship between BPD and behavior is complex. Cognitive, language, and motor skills mediate the effects of BPD grade on some problem behaviors.

Published
2019

5. Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic–Ischemic Encephalopathy in the Late Hypothermia Trial

Author

Abbot R. Laptook, Seetha Shankaran, Patrick Barnes, Nancy Rollins, Barbara T. Do, Nehal A. Parikh, Shannon Hamrick, Susan R. Hintz, Jon E. Tyson, Edward F. Bell, Namasivayam Ambalavanan, Ronald N. Goldberg, Athina Pappas, Carolyn Huitema, Claudia Pedroza, Aasma S. Chaudhary, Angelita M. Hensman, Abhik Das, Myra Wyckoff, Amir Khan, Michelle C. Walsh, Kristi L. Watterberg, Roger Faix, William Truog, Ronnie Guillet, Gregory M. Sokol, Brenda B. Poindexter, Rosemary D. Higgins, Michael S. Caplan, Richard A. Polin, Martin Keszler, William Oh, Betty R. Vohr, Elizabeth C. McGowan, Barbara Alksninis, Kristin Basso, Joseph Bliss, Carmena Bishop, Robert T. Burke, William Cashore, Melinda Caskey, Dan Gingras, Nicholas Guerina, Katharine Johnson, Mary Lenore Keszler, Andrea M. Knoll, Theresa M. Leach, Martha R. Leonard, Emilee Little, Bonnie E. Stephens, Elisa Vieira, Victoria E. Watson, Anna Maria Hibbs, Deanne E. Wilson-Costello, Nancy S. Newman, Beau Batton, Monika Bhola, Juliann M. Di Fiore, Harriet G. Friedman, Bonnie S. Siner, Eileen K. Stork, Gulgun Yalcinkaya, Arlene Zadell, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Knutson, Kurt Schibler, Kimberly Yolton, Cathy Grisby, Teresa L. Gratton, Stephanie Merhar, Sandra Wuertz, C. Michael Cotten, Kimberley A. Fisher, Sandra Grimes, Joanne Finkle, Ricki F. Goldstein, Kathryn E. Gustafson, William F. Malcolm, Patricia L. Ashley, Kathy J. Auten, Melody B. Lohmeyer, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Cindy Clark, Diane D. Warner, Janice Wereszcsak, Sofia Aliaga, David P. Carlton, Barbara J. Stoll, Ellen C. Hale, Yvonne Loggins, Diane I. Bottcher, Colleen Mackie, Maureen Mulligan LaRossa, Ira Adams-Chapman, Lynn C. Wineski, Sheena L. Carter, Stephanie Wilson Archer, Heidi M. Harmon, Lu-Ann Papile, Anna M. Dusick, Susan Gunn, Dianne E. Herron, Abbey C. Hines, Darlene Kardatzke, Carolyn Lytle, Heike M. Minnich, Leslie Richard, Lucy C. Smiley, Leslie Dawn Wilson, Kathleen A. Kennedy, Elizabeth Allain, Carrie M. Mason, Julie Arldt-McAlister, Katrina Burson, Allison G. Dempsey, Andrea F. Duncan, Patricia W. Evans, Carmen Garcia, Charles E. Green, Margarita Jimenez, Janice John, Patrick M. Jones, M. Layne Lillie, Karen Martin, Sara C. Martin, Georgia E. McDavid, Shannon McKee, Patti L. Pierce Tate, Shawna Rodgers, Saba Khan Siddiki, Daniel K. Sperry, Sharon L. Wright, Pablo J. Sánchez, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Christine A. Fortney, Jennifer L. Grothause, Dennis Wallace, Marie G. Gantz, Kristin M. Zaterka-Baxter, Margaret M. Crawford, Scott A. McDonald, Jamie E. Newman, Jeanette O'Donnell Auman, Carolyn M. Petrie Huitema, James W. Pickett, Patricia Yost, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, Barbara Bentley, Valerie Y. Chock, Elizabeth F. Bruno, Alexis S. Davis, Maria Elena DeAnda, Anne M. DeBattista, Beth Earhart, Lynne C. Huffman, Jean G. Kohn, Casey E. Krueger, Melinda S. Proud, William D. Rhine, Nicholas H. St. John, Heather Taylor, Hali E. Weiss, Waldemar A. Carlo, Myriam Peralta-Carcelen, Monica V. Collins, Shirley S. Cosby, Vivien A. Phillips, Richard V. Rector, Sally Whitley, Tarah T. Colaizy, Jane E. Brumbaugh, Karen J. Johnson, Diane L. Eastman, Michael J. Acarregui, Jacky R. Walker, Claire A. Goeke, Jonathan M. Klein, Nancy J. Krutzfield, Jeffrey L. Segar, John M. Dagle, Julie B. Lindower, Steven J. McElroy, Glenda K. Rabe, Robert D. Roghair, Lauritz R. Meyer, Dan L. Ellsbury, Donia B. Campbell, Cary R. Murphy, Vipinchandra Bhavsar, Robin K. Ohls, Conra Backstrom Lacy, Sandra Sundquist Beauman, Sandra Brown, Erika Fernandez, Andrea Freeman Duncan, Janell Fuller, Elizabeth Kuan, Jean R. Lowe, Barbara Schmidt, Haresh Kirpalani, Sara B. DeMauro, Kevin C. Dysart, Soraya Abbasi, Toni Mancini, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Hallam Hurt, Carl D'Angio, Satyan Lakshminrusimha, Nirupama Laroia, Gary J. Myers, Kelley Yost, Stephanie Guilford, Rosemary L. Jensen, Karen Wynn, Osman Farooq, Anne Marie Reynolds, Holly I.M. Wadkins, Ashley Williams, Joan Merzbach, Patrick Conway, Melissa Bowman, Michele Hartley-McAndrew, William Zorn, Cait Fallone, Kyle Binion, Constance Orme, Ann Marie Scorsone, Luc P. Brion, Lina F. Chalak, Roy J. Heyne, Lijun Chen, Diana M. Vasil, Sally S. Adams, Catherine Twell Boatman, Alicia Guzman, Elizabeth T. Heyne, Lizette E. Lee, Melissa H. Leps, Linda A. Madden, Nancy A. Miller, Emma Ramon, Bradley A. Yoder, Karen A. Osborne, Cynthia Spencer, R. Edison Steele, Mike Steffen, Karena Strong, Kimberlee Weaver-Lewis, Shawna Baker, Sarah Winter, Karie Bird, Jill Burnett, Beena G. Sood, Rebecca Bara, Kirsten Childs, Lilia C. De Jesus, Bogdan Panaitescu, Sanjay M.D. Chawla, Jeannette E. Prentice, Laura A. Goldston, Eunice Hinz Woldt, Girija Natarajan, Monika Bajaj, John Barks, Mary Christensen, and Stephanie A. Wiggins

Subjects
Male, Pediatrics, medicine.medical_specialty, Developmental Disabilities, Subgroup analysis, Severity of Illness Index, Article, Hypoxic Ischemic Encephalopathy, 03 medical and health sciences, 0302 clinical medicine, Hypothermia, Induced, Predictive Value of Tests, 030225 pediatrics, Multicenter trial, medicine, Humans, 030212 general & internal medicine, medicine.diagnostic_test, Neonatal encephalopathy, business.industry, Infant, Newborn, Area under the curve, Infant, Magnetic resonance imaging, Hypothermia, medicine.disease, Magnetic Resonance Imaging, Hypoxia-Ischemia, Brain, Pediatrics, Perinatology and Child Health, Gestation, Female, medicine.symptom, business, Infant, Premature
Abstract

Objective To investigate if magnetic resonance imaging (MRI) is an accurate predictor for death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours. Study design Subgroup analysis of infants ≥36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia. MRI scans were performed per each center's practice and interpreted by 2 central readers using the Eunice Kennedy Shriver National Institute of Child Health and Human Development injury score (6 levels, normal to hemispheric devastation). Neurodevelopmental outcomes were assessed at 18-22 months of age. Results Of 168 enrollees, 128 had an interpretable MRI and were seen in follow-up (n = 119) or died (n = 9). MRI findings were predominantly acute injury and did not differ by cooling treatment. At 18-22 months, death or severe disability occurred in 20.3%. No infant had moderate disability. Agreement between central readers was moderate (weighted kappa 0.56, 95% CI 0.45-0.67). The adjusted odds of death or severe disability increased 3.7-fold (95% CI 1.8-7.9) for each increment of injury score. The area under the curve for severe MRI patterns to predict death or severe disability was 0.77 and the positive and negative predictive values were 36% and 100%, respectively. Conclusions MRI injury scores were associated with neurodevelopmental outcome at 18-22 months among infants in the Late Hypothermia Trial. However, the results suggest caution when using qualitative interpretations of MRI images to provide prognostic information to families following perinatal hypoxia–ischemia. Trial registration Clinicaltrials.gov: NCT00614744 .

Published
2021

6. Improving publication rates in a collaborative clinical trials research network

Author

Carolyn M. Petrie Huitema, William E Truog, Stephanie Wilson Archer, Waldemar A. Carlo, Uday Devaskar, Krisa P. Van Meurs, David K. Stevenson, Margaret M. Crawford, Leif D. Nelin, Abhik Das, Rosemary D. Higgins, and Pablo J. Sánchez

Subjects
medicine.medical_specialty, Biomedical Research, Alternative medicine, Review Literature as Topic, Article, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, 030212 general & internal medicine, Cooperative Behavior, Publishing, Clinical Trials as Topic, Medical education, business.industry, Obstetrics and Gynecology, Authorship, Clinical trial, Pediatrics, Perinatology and Child Health, Cooperative behavior, Neonatology, Periodicals as Topic, business, Editorial Policies, 030217 neurology & neurosurgery
Abstract

Unpublished results can bias biomedical literature, favoring positive over negative findings, primary over secondary analyses, and can lead to duplicate studies that unnecessarily endanger subjects and waste resources. The Neonatal Research Networkʼs (NRN) publication policies for approving, reviewing, and tracking abstracts and papers work to combat these problems. In 2003, the NRN restricted investigators with unfinished manuscripts from proposing new ones and in 2010, urged authors to complete long-outstanding manuscripts. Data from 1991 to 2015 were analyzed to determine effectiveness of these policy changes. The NRN has achieved an overall publication rate of 78% for abstracts. For 1990–2002, of 137 abstracts presented, 43 (31%) were published within 2 years; for 2003–2009, after the manuscript completion policy was instituted, of 140 abstracts presented, 68 (49%) were published within 2 years. Following the effort in 2010, the rate increased to 64%. The NRN surpassed reported rates by developing a comprehensive process, holding investigators accountable and tracking abstracts from presentation to publication.

Published
2016

7. Neurodevelopmental and Behavioral Outcomes in Extremely Premature Neonates With Ventriculomegaly in the Absence of Periventricular-Intraventricular Hemorrhage

Author

Heike M. Minnich, Ivan D. Frantz, Karen J. Johnson, William E Truog, Sandra Brown, Ronnie Guillet, Myriam Peralta-Carcelen, Rosemary D. Higgins, Haresh Kirpalani, Kathryn E. Gustafson, Leslie Dawn Wilson, Gregory M Sokol, Catherine Twell Boatman, Edward F. Bell, Janet S. Morgan, W. Kenneth Poole, Amanda D. Soong, Jeanette O'Donnell Auman, Avroy A. Fanaroff, Katrina Burson, Gulgun Yalcinkaya, Monica Konstantino, Leif D. Nelin, Bradley A. Yoder, Carin Kiser, Kristin M. Basso, Marian M. Adams, Neil N. Finer, Dennis Wallace, Hali E. Weiss, Deanna Maffett, Hallam Hurt, Fred J. Biasini, Meena Garg, Laura Cole, Kathleen A. Kennedy, Julianne Hunn, Lucy Miller, Anne Holmes, Farooq Osman, Barbara Schmidt, Anna Marie Hibbs, Walid A. Salhab, Karen A. Osborne, M. Bethany Ball, Laura A. Goldston, Silvia M. Frade Eguaras, Faithe Hamer, Julie Babish Johnson, Ruth Everett-Thomas, Patti L. Pierce Tate, Maria Calejo, Michele C. Walsh, Eugenia K. Pallotto, Rachel Geller, Roger G. Faix, Melissa H. Leps, Maria Elena DeAnda, Ronald N. Goldberg, Marie G. Gantz, Sally Whitley, Nehal A. Parikh, Michelle Harwood Berkowits, Seetha Shankaran, Andrew W. Palmquist, Andrea Halbrook, Kimberlee Weaver-Lewis, Theresa M. Leach, Ira Adams-Chapman, Janice Bernhardt, Sarah Ryan, Maynard Rasmussen, Edward F. Donovan, Diana M. Vasil, Carroll Peterson, Jamie E. Newman, Bonnie E. Stephens, Karen A. Wynn, Myra H. Wyckoff, David P. Carlton, Jody Hessling, Barbara Alexander, Katherine A. Foy, Abbot R. Laptook, Michael Steffen, Sudarshan R. Jadcherla, Suzy Ventura, Raquel Halfond, Ana K. Brussa, Charles R. Rosenfeld, Ellen Waldrep, Peggy Robichaux, Donald J. Goldstein, Monika Bhola, Brenda H. Morris, Clarence Demetrio, Erica Burnell, Brenda B. Poindexter, Martha D. Carlson, Sharon L. Wright, Linda A. Madden, Michael S. Caplan, Isabell B. Purdy, Athina Pappas, Barbara Bentley, Carol Hartenberger, Patricia W. Evans, John A. Widness, Marsha Gerdes, Stephanie Wilson Archer, Kimberly Yolton, Christine G. Butler, Roy J. Heyne, Joanne Williams, Gaynelle Hensley, Carl L. Bose, Lu Ann Papile, Richard A. Polin, Brenda L. MacKinnon, JoAnn Poulsen, Anne Marie Reynolds, T. Michael O'Shea, Charles R. Bauer, Gary J. Myers, Joanne Finkle, Maegan C. Simmons, Shahnaz Duara, Arielle Rigaud, Jill Burnett, Jacky R. Walker, Lauren Zwetsch, Ellen Nylen, Margarita Jiminez, Christine A. Fortney, Angelita M. Hensman, Ellen C. Hale, Joan Merzbach, Teresa L. Gratton, Yvonne E. Vaucher, Kathy Arnell, Holly I.M. Wadkins, Sara Kryzwanski, Nancy A. Miller, Susan R. Hintz, Elaine Romano, Betty R. Vohr, Sara B. DeMauro, Donia B. Campbell, Dara M. Cucinotta, Anna Bodnar, Kristy Domnanovich, Angela Argento, Georgia E. McDavid, Kurt Schibler, Patricia L. Ashley, Margaret M. Crawford, Casey E. Krueger, Bonnie S. Siner, Sally S. Adams, Jane E. Brumbaugh, Korinne Chiu, Janice Wereszczak, Satyanarayana Lakshminrusimha, Jon E. Tyson, Carolyn Lytle, Toni Mancini, Nancy Peters, Gennie Bose, Cryshelle S. Patterson, Katharine Johnson, Barbara J. Stoll, Kristin Kirker, Gail Hounshell, Melinda S. Proud, Janet Taft, Dale L. Phelps, Keith Owen Yeates, Kathy Johnson, Dan L. Ellsbury, Martin Keszler, Leslie Rodrigues, Jennifer J. Jensen, Barbara Alksninis, Sandra Grimes, Wade Rich, Stephanie A. Wiggins, Krisa P. Van Meurs, Yvonne Loggins, M. Layne Poundstone, David Kaegi, Elizabeth T. Heyne, Sheena L. Carter, Patricia Cervone, Richard V. Rector, John M. Fiascone, Nora I. Alaniz, Helina Pierre, Waldemar A. Carlo, Kimberley A. Fisher, Elisabeth C. McGowan, Robert G. Dillard, Greg Muthig, Sarah Martin, Carolyn M. Petrie Huitema, Barbara G. Jackson, Brian G. Tang, Melinda Caskey, Vivien Phillips, Soraya Abbasi, Michael J. Acarregui, Andrea Garcia, Robert T. Burke, Aasma S. Chaudhary, Luc P. Brion, Jean G. Kohn, Kelley Yost, Melody B. Lohmeyer, Allison F. Payne, Harriet Friedman, Victoria E. Watson, William Oh, Nancy S. Newman, John Barks, Andrea H. Duncan, Pablo J. Sánchez, Mary Lenore Keszler, Deborah Evans Allred, Rosemary L. Jensen, Karie Bird, Kristin M. Zaterka-Baxter, Ann B. Cook, Alicia Guzman, Holly L. Mincey, Gail E. Besner, Kate Bridges, Sylvia Fajardo-Hiriart, Matthew M. Laughon, Cathy Grisby, Robin K. Ohls, Rebecca Bara, Karen Zanetti, Anne M. DeBattista, Tarah T. Colaizy, William F. Malcolm, Cherrie D. Welch, Judy Bernbaum, Melissa Whalen Morris, Kathleen G. Nelson, Scott A. McDonald, Emily Kushner, Abbey C. Hines, Sheila Greisman, Ashley Williams, Estelle E. Fischer, Lenora Jackson, Harris C. Jacobs, Cheri Gauldin, Alexandra Stoerger, Deanne E. Wilson-Costello, Rebecca Montman, Monica V. Collins, Mary Christensen, Charles Green, Mary Johnson, David K. Stevenson, Lijun Chen, Cecelia E. Sibley, Lisa K. Washburn, Maureen Mulligan LaRossa, Lizette E. Torres, Kathy J. Auten, Chris Henderson, U. Devaskar, Leigh Ann Smith, Janell Fuller, Diane L. Eastman, Anna E. Lis, Dianne E. Herron, Kristen C. Johnston, Anna M. Dusick, Martha G. Fuller, Anne Furey, Howard W. Kilbride, Jean R. Lowe, Elizabeth F. Bruno, Saba Siddiki, Abhik Das, Linda J. Reubens, Richard A. Ehrenkranz, Namasivayam Ambalavanan, Cynthia Spencer, Ricki F. Goldstein, Lynne C. Huffman, Teresa Chanlaw, Patricia Luzader, Carl T. D'Angio, Diane Hust, Radmila West, Beverly Foley Harris, Sarah Winter, Conra Backstrom Lacy, Shawna Baker, Shirley S. Cosby, C. Michael Cotten, and Kristi L. Watterberg

Subjects
Male, Pediatrics, medicine.medical_specialty, Gestational Age, Infant, Premature, Diseases, Bayley Scales of Infant Development, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, medicine, Humans, Longitudinal Studies, Original Investigation, Cerebral Hemorrhage, Retrospective Studies, Ultrasonography, business.industry, Cerebral Palsy, Infant, Newborn, Gestational age, Brain, Gross Motor Function Classification System, Odds ratio, medicine.disease, Prognosis, Intraventricular hemorrhage, Bronchopulmonary dysplasia, Neurodevelopmental Disorders, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Necrotizing enterocolitis, Female, business, 030217 neurology & neurosurgery, Ventriculomegaly, Hydrocephalus
Abstract

Importance Studies of cranial ultrasonography and early childhood outcomes among cohorts of extremely preterm neonates have linked periventricular-intraventricular hemorrhage and cystic periventricular leukomalacia with adverse neurodevelopmental outcomes. However, the association between nonhemorrhagic ventriculomegaly and neurodevelopmental and behavioral outcomes is not fully understood. Objective To characterize the outcomes of extremely preterm neonates younger than 27 weeks’ gestational age who experienced nonhemorrhagic ventriculomegaly that was detected prior to 36 weeks’ postmenstrual age. Design, Setting, and Participants This longitudinal observational study was conducted at 16 centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants born prior to 27 weeks’ gestational age in any network facility between July 1, 2006, and June 30, 2011, were included if they had a cranial ultrasonogram performed prior to 36 weeks’ postmenstrual age. Comparisons were made between those with ventriculomegaly and those with normal cranial sonograms. Data analysis was completed from August 2013 to August 2017. Main Outcomes and Measures The main outcome was neurodevelopmental impairment, defined as a Bayley Scales of Infant and Toddler Development III cognitive score less than 70, moderate/severe cerebral palsy, a Gross Motor Function Classification System score of level 2 or more, vision impairment, or hearing impairment. Secondary outcomes included Bayley Scales of Infant and Toddler Development III subscores, components of neurodevelopmental impairment, behavioral outcomes, and death/neurodevelopmental impairment. Logistic regression was used to evaluate the association of ventriculomegaly with adverse outcomes while controlling for potentially confounding variables and center differences as a random effect. Linear regression was used similarly for continuous outcomes. Results Of 4193 neonates with ultrasonography data, 300 had nonhemorrhagic ventriculomegaly (7%); 3045 had normal cranial ultrasonograms (73%), 775 had periventricular-intraventricular hemorrhage (18.5%), and 73 had cystic periventricular leukomalacia (1.7%). Outcomes were available for 3008 of 3345 neonates with ventriculomegaly or normal scans (90%). Compared with normal cranial ultrasonograms, ventriculomegaly was associated with lower gestational age, male sex, and bronchopulmonary dysplasia, late-onset sepsis, meningitis, necrotizing enterocolitis, and stage 3 retinopathy of prematurity. After adjustment, neonates with ventriculomegaly had higher odds of neurodevelopmental impairment (odds ratio [OR], 3.07; 95% CI, 2.13-4.43), cognitive impairment (OR, 3.23; 95% CI, 2.09-4.99), moderate/severe cerebral palsy (OR, 3.68; 95% CI, 2.08-6.51), death/neurodevelopmental impairment (OR, 2.17; 95% CI, 1.62-2.91), but not death alone (OR, 1.09; 95% CI, 0.76-1.57). Behavioral outcomes did not differ. Conclusions and Relevance Nonhemorrhagic ventriculomegaly is associated with increased odds of neurodevelopmental impairment among extremely preterm neonates.

Published
2017

8. Effect of Depth and Duration of Cooling on Death or Disability at Age 18 Months Among Neonates With Hypoxic-Ischemic Encephalopathy: A Randomized Clinical Trial

Author

Jane E. Brumbaugh, Shannon E. G. Hamrick, Seetha Shankaran, Athina Pappas, Rebecca Bara, Abhik Das, Michele C. Walsh, Edward G. Shepherd, Richard A. Ehrenkranz, Scott A. McDonald, Amir M. Khan, Heidi M. Harmon, Claudia Pedroza, Carolyn M. Petrie Huitema, Jon E. Tyson, Edward F. Bell, Krisa P. Van Meurs, Lina F. Chalak, Kristi L. Watterberg, Kurt Schibler, John D.E. Barks, Rosemary D. Higgins, C. Michael Cotten, Michelle Hartley-McAndrew, Howard W. Kilbride, Brenda B. Poindexter, Sara B. DeMauro, Namasivayam Ambalavanan, Cathy Grisby, Abbot R. Laptook, Roy J. Heyne, Meena Garg, and Uday Devaskar

Subjects
Male, Pediatrics, medicine.medical_specialty, Time Factors, Age adjustment, Encephalopathy, Bayley Scales of Infant Development, Hypoxic Ischemic Encephalopathy, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Hypothermia, Induced, 030225 pediatrics, medicine, Humans, Treatment Failure, Original Investigation, business.industry, Absolute risk reduction, Temperature, Infant, Newborn, Infant, Gross Motor Function Classification System, Bayes Theorem, General Medicine, medicine.disease, Death, Neurodevelopmental Disorders, Relative risk, Hypoxia-Ischemia, Brain, Female, Morbidity, business, 030217 neurology & neurosurgery
Abstract

Importance Hypothermia for 72 hours at 33.5°C for neonatal hypoxic-ischemic encephalopathy reduces death or disability, but rates continue to be high. Objective To determine if cooling for 120 hours or to a temperature of 32.0°C reduces death or disability at age 18 months in infants with hypoxic-ischemic encephalopathy. Design, Setting, and Participants Randomized 2 × 2 factorial clinical trial in neonates (≥36 weeks’ gestation) with hypoxic-ischemic encephalopathy at 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network between October 2010 and January 2016. Interventions A total of 364 neonates were randomly assigned to 4 hypothermia groups: 33.5°C for 72 hours (n = 95), 32.0°C for 72 hours (n = 90), 33.5°C for 120 hours (n = 96), or 32.0°C for 120 hours (n = 83). Main Outcomes and Measures The primary outcome was death or moderate or severe disability at 18 to 22 months of age adjusted for center and level of encephalopathy. Severe disability included any of Bayley Scales of Infant Development III cognitive score less than 70, Gross Motor Function Classification System (GMFCS) level of 3 to 5, or blindness or hearing loss despite amplification. Moderate disability was defined as a cognitive score of 70 to 84 and either GMFCS level 2, active seizures, or hearing with amplification. Results The trial was stopped for safety and futility in November 2013 after 364 of the planned 726 infants were enrolled. Among 347 infants (95%) with primary outcome data (mean age at follow-up, 20.7 [SD, 3.5] months; 42% female), death or disability occurred in 56 of 176 (31.8%) cooled for 72 hours and 54 of 171 (31.6%) cooled for 120 hours (adjusted risk ratio, 0.92 [95% CI, 0.68-1.25]; adjusted absolute risk difference, −1.0% [95% CI, −10.2% to 8.1%]) and in 59 of 185 (31.9%) cooled to 33.5°C and 51 of 162 (31.5%) cooled to 32.0°C (adjusted risk ratio, 0.92 [95% CI, 0.68-1.26]; adjusted absolute risk difference, −3.1% [95% CI, −12.3% to 6.1%]). A significant interaction between longer and deeper cooling was observed ( P = .048), with primary outcome rates of 29.3% at 33.5°C for 72 hours, 34.5% at 32.0°C for 72 hours, 34.4% at 33.5°C for 120 hours, and 28.2% at 32.0°C for 120 hours. Conclusions and Relevance Among term neonates with moderate or severe hypoxic-ischemic encephalopathy, cooling for longer than 72 hours, cooling to lower than 33.5°C, or both did not reduce death or moderate or severe disability at 18 months of age. However, the trial may be underpowered, and an interaction was found between longer and deeper cooling. These results support the current regimen of cooling for 72 hours at 33.5°C. Trial Registration clinicaltrials.gov Identifier:NCT01192776

Published
2017

9. Outcomes of Preterm Infants following Discussions about Withdrawal or Withholding of Life Support

Author

Jennifer James, David Munson, Sara B. DeMauro, John C. Langer, April R. Dworetz, Girija Natarajan, Margarita Bidegain, Christine A. Fortney, Ruth Seabrook, Betty R. Vohr, Jon E. Tyson, Edward F. Bell, Brenda B. Poindexter, Seetha Shankaran, Rosemary D. Higgins, Abhik Das, Barbara J. Stoll, Haresh Kirpalani, Michael S. Caplan, Abbot R. Laptook, Angelita M. Hensman, Elisa Vieira, Emilee Little, Robert Burke, Melinda Caskey, Katharine Johnson, Barbara Alksninis, Mary Lenore Keszler, Andrea M. Knoll, Theresa M. Leach, Elisabeth C. McGowan, Victoria E. Watson, Suzy Ventura, Michele C. Walsh, Avroy A. Fanaroff, Anna Marie Hibbs, Nancy S. Newman, Allison H. Payne, Deanne E. Wilson-Costello, Bonnie S. Siner, Monika Bhola, Gulgun Yalcinkaya, Harriet G. Friedman, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Knutson, Kurt Schibler, Barbara Alexander, Cathy Grisby, Teresa L. Gratton, Jean J. Steichen, Estelle E. Fischer, Lenora Jackson, Kristin Kirker, Greg Muthig, Stacey Tepe, Kimberly Yolton, Ronald N. Goldberg, C. Michael Cotten, Ricki F. Goldstein, William F. Malcolm, Patricia L. Ashley, Kimberley A. Fisher, Joanne Finkle, Kathryn E. Gustafson, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Gennie Bose, Janice Wereszczak, David P. Carlton, Ellen C. Hale, Ira Adams-Chapman, Yvonne Loggins, Stephanie Wilson Archer, Gregory M. Sokol, Lu-Ann Papile, Leslie Dawn Wilson, Dianne E. Herron, Susan Gunn, Lucy Smiley, Abbey C. Hines, Leif D. Nelin, Sudarshan R. Jadcherla, Pablo J. Sánchez, Patricia Luzader, Gail E. Besner, Nehal A. Parikh, Dennis Wallace, Marie G. Gantz, Jamie E. Newman, Jeanette O'Donnell Auman, Margaret Crawford, Carolyn M. Petrie Huitema, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, Susan R. Hintz, Melinda S. Proud, Barbara Bentley, Maria Elena DeAnda, Anne M. DeBattista, Beth Earhart, Lynne C. Huffman, Casey E. Krueger, Hali E. Weiss, Waldemar A. Carlo, Namasivayam Ambalavanan, Myriam Peralta-Carcelen, Monica V. Collins, Shirley S. Cosby, Fred J. Biasini, Kristen C. Johnston, Cryshelle S. Patterson, Vivien A. Phillips, Sally Whitley, Uday Devaskar, Meena Garg, Isabell B. Purdy, Teresa Chanlaw, Rachel Geller, Dan L. Ellsbury, Tarah T. Colaizy, Jane E. Brumbaugh, John A. Widness, Karen J. Johnson, Jacky R. Walker, Donia B. Campbell, Diane L. Eastman, Kristi L. Watterberg, Jean R. Lowe, Janell F. Fuller, Robin K. Ohls, Conra Backstrom Lacy, Andrea F. Duncan, Barbara Schmidt, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Judy C. Bernbaum, Marsha Gerdes, Hallam Hurt, Carl T. D'Angio, Ronnie Guillet, Satyan Lakshminrusimha, Anne Marie Reynolds, Rosemary L. Jensen, Joan Merzbach, Gary J. Myers, Ashley Williams, Kelley Yost, William Zorn, Karen Wynn, Deanna Maffett, Diane Prinzing, Julianne Hunn, Stephanie Guilford, Farooq Osman, Mary Rowan, Michael G. Sacilowski, Holly I.M. Wadkins, Melissa Bowman, Kathleen A. Kennedy, Julie Arldt-McAlister, Katrina Burson, Andrea Freeman Duncan, Carmen Garcia, Beverly Foley Harris, Janice John, Patrick M. Jones, Layne M. Lillie, Karen Martin, Sara C. Martin, Georgia E. McDavid, Shawna Rodgers, Saba Siddiki, Daniel Sperry, Patti L. Pierce Tate, Sharon L. Wright, Myra Wyckoff, Luc P. Brion, Diana M. Vasil, Lijun Chen, Roy J. Heyne, Sally S. Adams, Linda A. Madden, Elizabeth Heyne, Alicia Guzman, Lizette E. Torres, Catherine Twell Boatman, Athina Pappas, Rebecca Bara, Laura A. Goldston, John Barks, Mary Christensen, Stephanie Wiggins, and Diane White

Subjects
Male, Pediatrics, medicine.medical_specialty, Palliative care, Birth weight, Decision Making, Article, 03 medical and health sciences, 0302 clinical medicine, Early onset sepsis, 030225 pediatrics, Intensive care, Infant Mortality, Outcome Assessment, Health Care, medicine, Humans, 030212 general & internal medicine, Registries, Retrospective Studies, business.industry, Infant, Newborn, Gestational age, Infant, medicine.disease, Life Support Care, Survival Rate, Withholding Treatment, Life support, Pediatrics, Perinatology and Child Health, Necrotizing enterocolitis, Gestation, Female, Morbidity, business, Infant, Premature
Abstract

Objectives To describe the frequency of postnatal discussions about withdrawal or withholding of life-sustaining therapy (WWLST), ensuing WWLST, and outcomes of infants surviving such discussions. We hypothesized that such survivors have poor outcomes. Study design This retrospective review included registry data from 18 centers of the National Institute of Child Health and Human Development Neonatal Research Network. Infants born at 22-28 weeks of gestation who survived >12 hours during 2011-2013 were included. Regression analysis identified maternal and infant factors associated with WWLST discussions and factors predicting ensuing WWLST. In-hospital and 18- to 26-month outcomes were evaluated. Results WWLST discussions occurred in 529 (15.4%) of 3434 infants. These were more frequent at 22-24 weeks (27.0%) compared with 27-28 weeks of gestation (5.6%). Factors associated with WWLST discussion were male sex, gestational age (GA) of ≤24 weeks, birth weight small for GA, congenital malformations or syndromes, early onset sepsis, severe brain injury, and necrotizing enterocolitis. Rates of WWLST discussion varied by center (6.4%-29.9%) as did WWLST (5.2%-20.7%). Ensuing WWLST occurred in 406 patients; of these, 5 survived to discharge. Of the 123 infants for whom intensive care was continued, 58 (47%) survived to discharge. Survival after WWLST discussion was associated with higher rates of neonatal morbidities and neurodevelopmental impairment compared with babies for whom WWLST discussions did not occur. Significant predictors of ensuing WWLST were maternal age >25 years, necrotizing enterocolitis, and days on a ventilator. Conclusions Wide center variations in WWLST discussions occur, especially at ≤24 weeks GA. Outcomes of infants surviving after WWLST discussions are poor. Trial registration ClinicalTrials.gov : NCT00063063 .

Published
2017

10. Association between Policy Changes for Oxygen Saturation Alarm Settings and Neonatal Morbidity and Mortality in Infants Born Very Preterm

Author

David P. Carlton, Julie Arldt-McAlister, Maegan C. Simmons, Jody Hessling, Rebecca Bara, W. Kenneth Poole, Charles R. Rosenfeld, Brenda B. Poindexter, Andrea M. Knoll, Colleen Mackie, Kurt Schibler, Gregory M. Sokol, Dennis Wallace, Kathy J. Auten, Karen J. Johnson, Georgia E. McDavid, Yvonne Loggins, M. Bethany Ball, Carmen Garcia, Lucy Miller, Nancy A. Miller, Athina Pappas, Ellen C. Hale, Allison H. Payne, Kristin M. Basso, Carol H. Hartenberger, Carolyn M. Petrie Huitema, Shawna Rodgers, Edward F. Donovan, Estelle E. Fischer, Kristi L. Watterberg, Karen Martin, Gaynelle Hensley, Michele C. Walsh, Avroy A. Fanaroff, Luc P. Brion, Tarah T. Colaizy, Jon E. Tyson, David K. Stevenson, Lijun Chen, Kate Bridges, Andrew W. Palmquist, Seetha Shankaran, Marian M. Adams, Anna Maria Hibbs, Sara B. DeMauro, Dianne E. Herron, Diane I. Bottcher, Anna E. Lis, Girija Natarajan, John A. Widness, Marie G. Gantz, Emilee Little, Stephanie Wilson Archer, Shirley S. Cosby, Melissa H. Leps, Namasivayam Ambalavanan, Rosemary D. Higgins, Leslie Dawn Wilson, Joanne Finkle, C. Michael Cotten, Walid A. Salhab, Barbara D. Alexander, Ronald N. Goldberg, Barbara J. Stoll, Abhik Das, Elizabeth E. Foglia, Mary Hanson, Elisa Vieira, Beverly Foley Harris, Myra H. Wyckoff, Conra Backstrom Lacy, Diana M. Vasil, Kimberley A. Fisher, Holly L. Mincey, Magdy Ismail, Martin Keszler, A. R. Laptook, Sara C. Martin, Kristin Kirker, Melinda S. Proud, Robin K. Ohls, Kristin M. Zaterka-Baxter, Alicia Guzman, Angelita M. Hensman, Margaret M. Crawford, Nancy S. Newman, Lizette E. Lee, Benjamin Carper, Waldemar A. Carlo, Jennifer A. Keller, Krisa P. Van Meurs, Lenora Jackson, Greg Muthig, Monica V. Collins, Cathy Grisby, Patti L. Pierce Tate, Satyan Lakshminrusimha, Stacey Tepe, Katrina Burson, Kathleen A. Kennedy, Michael S. Caplan, Jeanette O'Donnell Auman, Sandra Sundquist Beauman, Jacky R. Walker, Lara Pavageau, Edward F. Bell, Janet S. Morgan, and Barbara Schmidt

Subjects
Pediatrics, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Retinopathy of prematurity, Retrospective cohort study, medicine.disease, Odds, 03 medical and health sciences, Pulse oximetry, ALARM, 0302 clinical medicine, Bronchopulmonary dysplasia, 030225 pediatrics, Pediatrics, Perinatology and Child Health, Necrotizing enterocolitis, medicine, sense organs, 030212 general & internal medicine, skin and connective tissue diseases, business, Oxygen saturation (medicine)
Abstract

Objective To determine the impact of policy changes for pulse oximetry oxygen saturation (SpO2) alarm limits on neonatal mortality and morbidity among infants born very preterm. Study design This was a retrospective cohort study of infants born very preterm in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants were classified based on treatment at a hospital with an SpO2 alarm policy change and study epoch (before vs after policy change). We used a generalized linear mixed model to determine the effect of hospital group and epoch on the primary outcomes of mortality and severe retinopathy of prematurity (ROP) and secondary outcomes of necrotizing enterocolitis, bronchopulmonary dysplasia, and any ROP. Results There were 3809 infants in 10 hospitals with an SpO2 alarm policy change and 3685 infants in 9 hospitals without a policy change. The nature of most policy changes was to narrow the SpO2 alarm settings. Mortality was lower in hospitals without a policy change (aOR 0.63; 95% CI 0.50-0.80) but did not differ between epochs in policy change hospitals. The odds of bronchopulmonary dysplasia were greater for hospitals with a policy change (aOR 1.65; 95% CI 1.36-2.00) but did not differ for hospitals without a policy change. Severe ROP and necrotizing enterocolitis did not differ between epochs for either group. The adjusted odds of any ROP were lower in recent years in both hospital groups. Conclusions Changing SpO2 alarm policies was not associated with reduced mortality or increased severe ROP among infants born very preterm.

Published
2019

11. Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort

Author

Charles R. Rosenfeld, Marcia Worley Mersmann, Edward F. Bell, Kristin M. Zaterka-Baxter, Kristi L. Watterberg, Alicia Guzman, Lucy Miller, Ruth Everett-Thomas, James P. Kiley, Faithe Hamer, Marie G. Gantz, M. Bethany Ball, Beverly Foley Harris, Karen J. Johnson, Conra Backstrom Lacy, Susan Barnett, Kate Bridges, Sarah Lillie, Pat Cervone, Laura Grau, Gaynelle Hensley, Kerry Wilder, Richard A. Ehrenkranz, Ellen C. Hale, Maynard Rasmussen, David K. Stevenson, Kristen Angela, Betty K. Hastings, Kurt Schibler, Angelita M. Hensman, Nancy S. Newman, Amy K. Hutchinson, Kim Francis, Nancy Peters, Mary Anne Berberich, Dennis Wallace, Beena G. Sood, Brenda H. Morris, Michele C. Walsh, Michael S. Caplan, John A. Widness, Harris C. Jacobs, Dawn Andrews, Krisa P. Van Meurs, Stephanie Wilson Archer, Mary Johnson, Ivan D. Frantz, Nathan Morris, Sarah Martin, Alan H. Jobe, Diana M. Vasil, T. Michael O'Shea, Shahnaz Duara, Carolyn M. Petrie Huitema, Ronald N. Goldberg, Dale L. Phelps, Margaret M. Crawford, Sharon F. Freedman, Shirley S. Cosby, Jeanette O'Donnell Auman, C. Michael Cotten, Ellen Nylen, Monica V. Collins, Elizabeth Billian, Patricia Gettner, Kathleen A. Kennedy, Richard A. Polin, Waldemar A. Carlo, Avroy A. Fanaroff, Roger G. Faix, Gary David Markowitz, James A. Lemons, Katherine A. Foy, Abbot R. Laptook, James Allen, Brenda B. Poindexter, Kimberly A. Fisher, Bradley A. Yoder, David K. Wallace, Seetha Shankaran, Walid A. Salhab, Brenda L. MacKinnon, JoAnn Poulsen, Kimberlee Weaver-Lewis, Susie Buchter, Karen A. Osborne, Nancy A. Miller, Jill Burnett, Arlene Zadell, William Oh, Sharon L. Wright, Juliann M. Di Fiore, Kathy J. Auten, Namasivayam Ambalavanan, Vineet Bhandari, Barbara Alexander, Renee Bridge, Melinda S. Proud, Holly L. Mincey, Julie Rohr, Janet Taft, Cynthia Spencer, Cathy Grisby, Robin K. Ohls, Bonnie S. Siner, Monica Konstantino, Abhik Das, Patti L. Pierce Tate, Paul Wozniak, Melissa Martin, Linda J. Reubens, Barbara J. Stoll, Jennifer J. Jensen, Hong Li, Anthony J. Piazza, David P. Carlton, Wade Rich, Dianne E. Herron, Amanda R. Irene, Vivien Phillips, Georgia E. McDavid, Jody Hessling, Araceli Solis, Carol J. Blaisdell, Erica Burnell, Nirupama Laroia, Richard J. Martin, Kathy Arnell, Rebecca Bara, Clarence Demetrio, John M. Fiascone, Jonathan M. Klein, Anna E. Lis, Melissa H. Lepps, Vivek Narendran, Anne Furey, Jon E. Tyson, Edward F. Donovan, Dan Gingras, James W. Pickett, Rosemary D. Higgins, Leslie Dawn Wilson, Pablo J. Sánchez, Dorothy B. Gail, and Neil N. Finer

Subjects
Male, medicine.medical_specialty, Pediatrics, medicine.medical_treatment, Positive pressure, Gestational Age, Infant, Premature, Diseases, Article, Hypoxemia, Cohort Studies, 03 medical and health sciences, Surface-Active Agents, 0302 clinical medicine, 030225 pediatrics, Internal medicine, Medicine, Humans, 030212 general & internal medicine, Continuous positive airway pressure, Hypoxia, Oxygen saturation, Survival rate, Continuous Positive Airway Pressure, business.industry, Hazard ratio, Infant, Newborn, Oxygen Inhalation Therapy, Infant, Pulmonary Surfactants, Oxygenation, medicine.disease, Oxygen, Survival Rate, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Infant, Small for Gestational Age, Cardiology, Small for gestational age, Female, medicine.symptom, business
Abstract

Objective To characterize actual achieved patterns of oxygenation in infants born appropriate vs small for gestational age (SGA) randomized to a lower (85-89%) vs higher (91%-95%) oxygen saturation target in the Surfactant Positive Pressure and Oxygen Trial. To determine the association between achieved oxygen saturation levels and survival in infants born appropriate vs SGA enrolled in the Surfactant Positive Pressure and Oxygen Trial. Study design Median oxygen saturation and intermittent hypoxemia events ( 0/7 -27 6/7 weeks of gestation while receiving supplemental oxygen during the first 3 days of life. Results Lower target infants who were small for gestational age had the lowest oxygen saturation and highest incidence of intermittent hypoxemia during the first 3 days of life. The lowest quartile of oxygen saturation (≤92%) during the first 3 days of life was associated with lower 90-day survival for both infants born appropriate and SGA. An increased incidence of intermittent hypoxemia events during the first 3 days of life was associated with lower 90-day survival only in infants born SGA. Conclusion Lower achieved oxygen saturation during the first 3 days of life was associated with lower 90-day survival in extremely preterm infants. Infants born SGA had enhanced vulnerability to lower oxygen saturation targets as evidenced by lower achieved oxygen saturation and an association between increased intermittent hypoxemia events and lower survival. Trial registration ClinicalTrials.gov: NCT00233324.

Published
2016

12. Childhood Outcomes after Hypothermia for Neonatal Encephalopathy

Author

Seetha, Shankaran, Athina, Pappas, Scott A, McDonald, Betty R, Vohr, Susan R, Hintz, Kimberly, Yolton, Kathryn E, Gustafson, Theresa M, Leach, Charles, Green, Rebecca, Bara, Carolyn M, Petrie Huitema, Richard A, Ehrenkranz, Jon E, Tyson, Abhik, Das, Jane, Hammond, Myriam, Peralta-Carcelen, Patricia W, Evans, Roy J, Heyne, Deanne E, Wilson-Costello, Yvonne E, Vaucher, Charles R, Bauer, Anna M, Dusick, Ira, Adams-Chapman, Ricki F, Goldstein, Ronnie, Guillet, Lu-Ann, Papile, Rosemary D, Higgins, and Susan, DeLancy

Subjects
Male, Pediatrics, medicine.medical_specialty, Developmental Disabilities, Intelligence, Encephalopathy, Cerebral palsy, law.invention, Randomized controlled trial, Hypothermia, Induced, law, Intellectual Disability, Intellectual disability, medicine, Humans, Intelligence Tests, Asphyxia Neonatorum, Intelligence quotient, business.industry, Neonatal encephalopathy, Cerebral Palsy, Infant, Newborn, Obstetrics and Gynecology, Cognition, General Medicine, Hypothermia, medicine.disease, Early results, Child, Preschool, Hypoxia-Ischemia, Brain, Female, medicine.symptom, business, Psychosocial
Abstract

We previously reported early results of a randomized trial of whole-body hypothermia for neonatal hypoxic-ischemic encephalopathy showing a significant reduction in the rate of death or moderate or severe disability at 18 to 22 months of age. Long-term outcomes are now available.In the original trial, we assigned infants with moderate or severe encephalopathy to usual care (the control group) or whole-body cooling to an esophageal temperature of 33.5°C for 72 hours, followed by slow rewarming (the hypothermia group). We evaluated cognitive, attention and executive, and visuospatial function; neurologic outcomes; and physical and psychosocial health among participants at 6 to 7 years of age. The primary outcome of the present analyses was death or an IQ score below 70.Of the 208 trial participants, primary outcome data were available for 190. Of the 97 children in the hypothermia group and the 93 children in the control group, death or an IQ score below 70 occurred in 46 (47%) and 58 (62%), respectively (P=0.06); death occurred in 27 (28%) and 41 (44%) (P=0.04); and death or severe disability occurred in 38 (41%) and 53 (60%) (P=0.03). Other outcome data were available for the 122 surviving children, 70 in the hypothermia group and 52 in the control group. Moderate or severe disability occurred in 24 of 69 children (35%) and 19 of 50 children (38%), respectively (P=0.87). Attention-executive dysfunction occurred in 4% and 13%, respectively, of children receiving hypothermia and those receiving usual care (P=0.19), and visuospatial dysfunction occurred in 4% and 3% (P=0.80).The rate of the combined end point of death or an IQ score of less than 70 at 6 to 7 years of age was lower among children undergoing whole-body hypothermia than among those undergoing usual care, but the differences were not significant. However, hypothermia resulted in lower death rates and did not increase rates of severe disability among survivors. (Funded by the National Institutes of Health and the Eunice Kennedy Shriver NICHD Neonatal Research Network; ClinicalTrials.gov number, NCT00005772.).

Published
2012

13. Outcome of Preterm Infants with Transient Cystic Periventricular Leukomalacia on Serial Cranial Imaging Up to Term Equivalent Age

Author

Subrata Sarkar, Seetha Shankaran, John Barks, Barbara T. Do, Abbot R. Laptook, Abhik Das, Namasivayam Ambalavanan, Krisa P. Van Meurs, Edward F. Bell, Pablo J. Sanchez, Susan R. Hintz, Myra H. Wyckoff, Barbara J. Stoll, Waldemar A. Carlo, Alan H. Jobe, Michael S. Caplan, Richard A. Polin, Martin Keszler, William Oh, Betty R. Vohr, Angelita M. Hensman, Barbara Alksninis, Kristin M. Basso, Robert Burke, Melinda Caskey, Katharine Johnson, Mary Lenore Keszler, Andrea M. Knoll, Theresa M. Leach, Emilee Little, Elisabeth C. McGowan, Elisa Vieira, Victoria E. Watson, Suzy Ventura, Michele C. Walsh, Avroy A. Fanaroff, Anna Marie Hibbs, Deanne E. Wilson-Costello, Nancy S. Newman, Allison H. Payne, Bonnie S. Siner, Monika Bhola, Gulgun Yalcinkaya, Harriet G. Friedman, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Knutson, Kurt Schibler, Edward F. Donovan, Cathy Grisby, Kate Bridges, Barbara Alexander, Estelle E. Fischer, Holly L. Mincey, Jody Hessling, Teresa L. Gratton, Lenora Jackson, Kristin Kirker, Greg Muthig, Jean J. Steichen, Stacey Tepe, Marcia Worley Mersmann, Kimberly Yolton, Ronald N. Goldberg, C. Michael Cotten, Ricki F. Goldstein, Patricia L. Ashley, William F. Malcolm, Kathy J. Auten, Kimberley A. Fisher, Sandra Grimes, Kathryn E. Gustafson, Melody B. Lohmeyer, Joanne Finkle, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Gennie Bose, Diane Warner, Janice Wereszczak, David P. Carlton, Ira Adams-Chapman, Ellen C. Hale, Yvonne Loggins, Ann M. Blackwelder, Diane I. Bottcher, Colleen Mackie, Rosemary D. Higgins, Stephanie Wilson Archer, Gregory M. Sokol, Brenda B. Poindexter, James A. Lemons, Anna M. Dusick, Lu-Ann Papile, Carolyn Lytle, Abbey C. Hines, Heike M. Minnich, Dianne E. Herron, Lucy Smiley, Susan Gunn, Leslie Dawn Wilson, Kathleen A. Kennedy, Jon E. Tyson, Georgia E. McDavid, Esther G. Akpa, Julie Arldt-McAlister, Nora I. Alaniz, Katrina Burson, Pamela J. Bradt, Susan Dieterich, Allison Dempsey, Andrea F. Duncan, Patricia W. Evans, Claudia I. Franco, Carmen Garcia, Charles Green, Beverly Foley Harris, Margarita Jiminez, Janice John, Patrick M. Jones, Layne M. Lillie, Anna E. Lis, Terri Major-Kincade, Karen Martin, Sara C. Martin, Brenda H. Morris, Patricia Ann Orekoya, Stacey Reddoch, Shawna Rodgers, Saba Siddiki, Maegan C. Simmons, Daniel Sperry, Patti L. Pierce Tate, Laura L. Whitely, Sharon L. Wright, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Christine A. Fortney, Gail E. Besner, Nehal A. Parikh, Dennis Wallace, Marie G. Gantz, W. Kenneth Poole, Margaret M. Crawford, Jenna Gabrio, Betty K. Hastings, Jamie E. Newman, Jeanette O'Donnell Auman, Carolyn M. Petrie Huitema, Kristin M. Zaterka-Baxter, David K. Stevenson, M. Bethany Ball, Marian M. Adams, Alexis S. Davis, Andrew W. Palmquist, Melinda S. Proud, Barbara Bentley, Elizabeth Bruno, Maria Elena DeAnda, Anne M. DeBattista, Beth Earhart, Lynne C. Huffman, Jean G. Kohn, Casey Krueger, Hali E. Weiss, Ivan D. Frantz, John M. Fiascone, Brenda L. MacKinnon, Anne Furey, Ellen Nylen, Myriam Peralta-Carcelen, Monica V. Collins, Shirley S. Cosby, Fred J. Biasini, Kristen C. Johnston, Kathleen G. Nelson, Cryshelle S. Patterson, Vivien A. Phillips, Sally Whitley, Uday Devaskar, Meena Garg, Isabell B. Purdy, Teresa Chanlaw, Rachel Geller, Neil N. Finer, David Kaegi, Maynard R. Rasmussen, Paul R. Wozniak, Kathy Arnell, Clarence Demetrio, Martha G. Fuller, Chris Henderson, Wade Rich, Yvonne E. Vaucher, Tarah T. Colaizy, Michael J. Acarregui, Jane E. Brumbaugh, Dan L. Ellsbury, John A. Widness, Karen J. Johnson, Donia B. Campbell, Diane L. Eastman, Nancy J. Krutzfield, Shahnaz Duara, Charles R. Bauer, Ruth Everett-Thomas, Sylvia Fajardo-Hiriart, Arielle Rigaud, Maria Calejo, Silvia M. Frade Eguaras, Michelle Harwood Berkowits, Andrea Garcia, Helina Pierre, Alexandra Stoerger, Kristi L. Watterberg, Jean R. Lowe, Tara Dupont, Janell F. Fuller, Robin K. Ohls, Conra Backstrom Lacy, Rebecca Montman, Barbara Schmidt, Haresh Kirpalani, Sara B. DeMauro, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Hallam Hurt, Noah Cook, Carl T. D'Angio, Dale L. Phelps, Ronnie Guillet, Satyan Lakshminrusimha, Julie Babish Johnson, Erica Burnell, Linda J. Reubens, Cassandra A. Horihan, Rosemary L. Jensen, Emily Kushner, Joan Merzbach, Gary J. Myers, Mary Rowan, Holly I.M. Wadkins, Anne Marie Scorsone, Melissa Bowman, Julianne Hunn, Stephanie Guilford, Deanna Maffett, Osman Farooq, Diane Prinzing, Anne Marie Reynolds, Michael G. Sacilowski, Ashley Williams, Karen Wynn, Kelley Yost, William Zorn, Lauren Zwetsch, Luc P. Brion, R. Sue Broyles, Roy J. Heyne, Merle Ipson, Walid A. Salhab, Charles R. Rosenfeld, Diana M. Vasil, Lijun Chen, Alicia Guzman, Gaynelle Hensley, Jackie F. Hickman, Melissa H. Leps, Susie Madison, Nancy A. Miller, Janet S. Morgan, Lara Pavageau, Sally S. Adams, Cristin Dooley, Elizabeth T. Heyne, Lizette E. Lee, Linda A. Madden, Catherine Twell Boatman, Roger G. Faix, Bradley A. Yoder, Karen A. Osborne, Cynthia Spencer, Kimberlee Weaver-Lewis, Shawna Baker, Karie Bird, Jill Burnett, Michael Steffen, Jennifer J. Jensen, Sarah Winter, Karen Zanetti, T. Michael O'Shea, Robert G. Dillard, Lisa K. Washburn, Barbara G. Jackson, Nancy J. Peters, Korinne Chiu, Deborah Evans Allred, Donald J. Goldstein, Raquel Halfond, Carroll Peterson, Ellen L. Waldrep, Cherrie D. Welch, Melissa Whalen Morris, Gail Wiley Hounshell, Athina Pappas, Rebecca Bara, Laura A. Goldston, Geraldine Muran, Girija Natarajan, Mary Christensen, Stephanie A. Wiggins, Diane White, Richard A. Ehrenkranz, Harris Jacobs, Christine G. Butler, Patricia Cervone, Patricia Gettner, Sheila Greisman, Monica Konstantino, JoAnn Poulsen, Elaine Romano, Janet Taft, and Joanne Williams

Subjects
Male, congenital, hereditary, and neonatal diseases and abnormalities, Pediatrics, medicine.medical_specialty, Adverse outcomes, Developmental Disabilities, Leukomalacia, Periventricular, Gestational Age, Article, 03 medical and health sciences, Neonatal Screening, 0302 clinical medicine, Risk Factors, 030225 pediatrics, medicine, Humans, Prospective Studies, cardiovascular diseases, reproductive and urinary physiology, Ultrasonography, business.industry, Term equivalent age, Infant, Newborn, Brain, Infant, Cystic Periventricular Leukomalacia, nervous system diseases, Logistic Models, Increased risk, nervous system, Case-Control Studies, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Gestation, Female, business, 030217 neurology & neurosurgery
Abstract

OBJECTIVE: To determine the outcome of preterm infants whose cystic periventricular leukomalacia “disappeared” on serial screening cranial imaging studies. STUDY DESIGN: Infants ≤26 weeks of gestation born between 2002 and 2012 who had cranial imaging studies at least twice, the most abnormal study at

Published
2018

14. Effect of depth and duration of cooling on deaths in the NICU among neonates with hypoxic ischemic encephalopathy: a randomized clinical trial

Author

Susan Gunn, Stephanie Guilford, Lisa Sulkowski, Shannon E. G. Hamrick, David P. Carlton, Cathy Grisby, Sara B. De Mauro, Scott A. McDonald, Amir M. Khan, Christine A. Gleason, Jeffrey L. Segar, Sandra Grimes, William E. Truog, Lenora Jackson, Conra Backstrom Lacy, Cheri Gauldin, Kimberley A. Fisher, Carmen Garcia, Jacky R. Walker, Nancy S. Newman, Brenda B. Poindexter, Nirupama Laroia, Monica V. Collins, Jonathan M. Klein, Ellen C. Hale, Jeffrey R. Parker, Emilee Little, Tracy L. Nolen, Carol K. Redmond, Sandra Sundquist Beauman, Namasivayam Ambalavanan, Toni Mancini, Richard A. Polin, Aasma S. Chaudhary, Janice Bernhardt, Athina Pappas, Alexis S. Davis, Emma Ramon, Kathleen Weingarden, Laura Sumner, Edward F. Bell, Edward G. Shepherd, Karen J. Johnson, Beena G. Sood, Holly I.M. Wadkins, Robert D. Roghair, Patrick J. Conway, Julie Arldt-McAlister, Mary E. Johnson, Kevin Dysart, Myra H. Wyckoff, Lina F. Chalak, Ann Marie Scorsone, Donia B. Campbell, Rebecca Bara, Howard W. Kilbride, Anne Marie Reynolds, Dennis Wallace, Soraya Abbasi, Satyanarayana Lakshminrusimha, Carl L. Bose, Jon E. Tyson, Kathy Johnson, Ronnie Guillet, Robert T. Burke, Sharon L. Wright, Jeanette O'Donnell Auman, Teresa Chanlaw, Glenda K. Rabe, Suhas G. Kallapur, Ashley Williams, Gail E. Besner, Elisa Vierira, Stephanie Wilson Archer, Waldemar A. Carlo, Greg Muthig, Leslie T. McKinley, Sandra Wuertz, Shirley S. Cosby, Kristin Kirker, Melinda S. Proud, Melinda Caskey, Angelita M. Hensman, Kimberly Hayes-Hart, Karen Martin, Claudia Pedroza, Eugenia K. Pallotto, Carolyn M. Petrie Huitema, Lauritz R. Meyer, Jane E. Brumbaugh, Patricia Luzader, Jamie E. Newman, Georgia E. McDavid, Joanne Finkle, Meena Garg, Carl T. D'Angio, Vipinchandra Bhavsar, Krisa P. Van Meurs, Anne Holmes, Sudarshan R. Jadcherla, Ross Sommers, John D.E. Barks, Rosemary D. Higgins, Traci E Clemons, Leslie Dawn Wilson, Michael G. Sacilowski, Karen A. Wynn, Martin Keszler, Kristi L. Watterberg, Nicole Walker, Christine A. Fortney, Stephanie A. Wiggins, Cary R. Murphy, Marian Willinger, Michael S. Caplan, Betty R. Vohr, Rachel Geller, Ronald N. Goldberg, Margaret M. Crawford, Lucy Smiley, Steven J. Weiner, Dara M. Cucinotta, Barbara Schmidt, Mary E. D'Alton, Tarah T. Colaizy, John M. Dagle, Robin K. Ohls, Gregory M Sokol, Yvonne Loggins, Katrina Burson, Luc P. Brion, Kathleen A. Kennedy, Pablo J. Sánchez, Abbot R. Laptook, Ronald J. Wong, Roy J. Heyne, Anna Maria Hibbs, Haresh Kirpalani, Andrea Halbrook, Carol Kibler, Seetha Shankaran, Patti L. Pierce Tate, Carol H. Hartenberger, Steven J. McElroy, Dan L. Ellsbury, Diana M. Vasil, Teresa L. Gratton, Kurt Schibler, M. Bethany Ball, Michele C. Walsh, Nehal A. Parikh, Maria Batts, Abhik Das, Richard A. Ehrenkranz, Dianne E. Herron, Birju A. Shah, Marian M. Adams, Jenna Gabrio, Jennifer Jennings, Cindy Clark, Barbara J. Stoll, Robert J. Boyle, Matthew M. Laughon, Marie Gantz, Lilia C. De Jesus, Julie B. Lindower, U. Devaskar, Shawna Rodgers, Estelle E. Fischer, Kristin M. Zaterka-Baxter, Mary Christensen, David K. Stevenson, Lijun Chen, Michael G. Ross, Girija Natarajan, Nicholas Guerina, and Barbara D. Alexander

Subjects
Male, Neonatal intensive care unit, Time Factors, Developmental Disabilities, Hypothermia, Reproductive health and childbirth, Arrhythmias, Medical and Health Sciences, Hypoxic Ischemic Encephalopathy, law.invention, Randomized controlled trial, law, Hypothermia, Induced, Neonatal, Infant Mortality, Medicine, Duration (project management), Pediatric, Mortality rate, Temperature, Brain, Obstetrics and Gynecology, General Medicine, Intensive Care Units, Anesthesia, Hypoxia-Ischemia, Brain, Female, medicine.symptom, Acidosis, Cardiac, medicine.medical_specialty, Clinical Trials and Supportive Activities, Hemorrhage, Article, Clinical Research, General & Internal Medicine, Intensive Care Units, Neonatal, Hypoxia-Ischemia, Humans, Survival analysis, business.industry, Induced, Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network, Infant, Newborn, Infant, Arrhythmias, Cardiac, Thrombosis, Perinatal Period - Conditions Originating in Perinatal Period, Newborn, Survival Analysis, Surgery, Clinical trial, Relative risk, business
Abstract

Importance Hypothermia at 33.5°C for 72 hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to 44% to 55%; longer cooling and deeper cooling are neuroprotective in animal models. Objective To determine if longer duration cooling (120 hours), deeper cooling (32.0°C), or both are superior to cooling at 33.5°C for 72 hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy. Design, Setting, and Participants A randomized, 2 × 2 factorial design clinical trial performed in 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between October 2010 and November 2013. Interventions Neonates were assigned to 4 hypothermia groups; 33.5°C for 72 hours, 32.0°C for 72 hours, 33.5°C for 120 hours, and 32.0°C for 120 hours. Main Outcomes and Measures The primary outcome of death or disability at 18 to 22 months is ongoing. The independent data and safety monitoring committee paused the trial to evaluate safety (cardiac arrhythmia, persistent acidosis, major vessel thrombosis and bleeding, and death in the neonatal intensive care unit [NICU]) after the first 50 neonates were enrolled, then after every subsequent 25 neonates. The trial was closed for emerging safety profile and futility analysis after the eighth review with 364 neonates enrolled (of 726 planned). This report focuses on safety and NICU deaths by marginal comparisons of 72 hours’ vs 120 hours’ duration and 33.5°C depth vs 32.0°C depth (predefined secondary outcomes). Results The NICU death rates were 7 of 95 neonates (7%) for the 33.5°C for 72 hours group, 13 of 90 neonates (14%) for the 32.0°C for 72 hours group, 15 of 96 neonates (16%) for the 33.5°C for 120 hours group, and 14 of 83 neonates (17%) for the 32.0°C for 120 hours group. The adjusted risk ratio (RR) for NICU deaths for the 120 hours group vs 72 hours group was 1.37 (95% CI, 0.92-2.04) and for the 32.0°C group vs 33.5°C group was 1.24 (95% CI, 0.69-2.25). Safety outcomes were similar between the 120 hours group vs 72 hours group and the 32.0°C group vs 33.5°C group, except major bleeding occurred among 1% in the 120 hours group vs 3% in the 72 hours group (RR, 0.25 [95% CI, 0.07-0.91]). Futility analysis determined that the probability of detecting a statistically significant benefit for longer cooling, deeper cooling, or both for NICU death was less than 2%. Conclusions and Relevance Among neonates who were full-term with moderate or severe hypoxic ischemic encephalopathy, longer cooling, deeper cooling, or both compared with hypothermia at 33.5°C for 72 hours did not reduce NICU death. These results have implications for patient care and design of future trials. Trial Registration clinicaltrials.gov Identifier:NCT01192776

Published
2014

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