14 results on '"Ghadge, Alpana"'
Search Results
2. Placental transfusion in preterm neonates of 30–33 weeks’ gestation: a randomized controlled trial
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Das, Bikramjit, Sundaram, Venkataseshan, Tarnow-Mordi, William, Ghadge, Alpana, Dhaliwal, Lakhbir, and Kumar, Praveen
- Abstract
To compare effect of placental transfusion by delayed cord clamping (DCC) or cord milking (CM) with early cord clamping (ECC) on a composite of mortality or abnormal neurological status at 40 weeks’ post-menstrual age (PMA) and 24–30 months’ chronological age in neonates of 30–33 weeks’ gestation. Randomized, controlled trial. A composite of mortality or abnormal neurological status at 40 weeks PMA and survival free of neurodevelopmental abnormalities at 24–30 months’ chronological age. A total of 461 neonates were randomized to placental transfusion (n?=?233) or to ECC (n?=?228). Among those assigned to placental transfusion group, 173 underwent DCC while in the remaining 60, CM was done. Incidence of mortality or abnormal neurological status at 40 weeks PMA (43 (18%) vs 35 (15%), RR (95% CI) 1.2 (0.8, 1.8), p?=?0.4) and survival free of neurodevelopmental impairment at 24–30 months of chronological age (99 (47%) vs. 100 (50%); RR (95% CI): 0.9 (0.8, 1.2); P?=?0.9) was similar between the study groups. The placental transfusion group showed a trend towards lower incidence of necrotizing enterocolitis. In 30–33 weeks’ gestation preterm neonates, placental transfusion as compared to early cord clamping resulted in similar mortality or abnormal neurological status at 40 weeks PMA and at 24–30 months of chronological age.
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- 2024
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3. Randomized Controlled Trial of Oxygen Saturation Targets in Very Preterm Infants: Two Year Outcomes
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Darlow, Brian A., Marschner, Simone L., Donoghoe, Mark, Battin, Malcolm R., Broadbent, Roland S., Elder, Mark J., Hewson, Michael P., Meyer, Michael P., Ghadge, Alpana, Graham, Patricia, McNeill, Nicolette J., Kuschel, Carl A., and Tarnow-Mordi, William O.
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- 2014
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4. Delayed Versus Immediate Cord Clamping in Preterm Infants
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Tarnow-Mordi, William, Morris, Jonathan, Kirby, Adrienne, Robledo, Kristy, Askie, Lisa, Brown, Rebecca, Evans, Nicholas, Finlayson, Sarah, Fogarty, Michael, Gebski, Val, Ghadge, Alpana, Hague, Wendy, Isaacs, David, Jeffery, Michelle, Keech, Anthony, Kluckow, Martin, Popat, Himanshu, Sebastian, Lucille, Aagaard, Kjersti, Belfort, Michael, Pammi, Mohan, Abdel-Latif, Mohamed, Reynolds, Graham, Ariff, Shabina, Sheikh, Lumaan, Chen, Yan, Colditz, Paul, Liley, Helen, Pritchard, Margo, de Luca, Daniele, de Waal, Koert, Forder, Peta, Duley, Lelia, El-Naggar, Walid, Gill, Andrew, Newnham, John, Simmer, Karen, Groom, Katie, Weston, Philip, Gullam, Joanna, Patel, Harshad, Koh, Guan, Lui, Kei, Marlow, Neil, Morris, Scott, Sehgal, Arvind, Wallace, Euan, Soll, Roger, Young, Leslie, Sweet, David, Walker, Susan, Watkins, Andrew, Wright, Ian, Osborn, David, and Simes, John
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- 2018
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5. Delayed versus Immediate Cord Clamping in Preterm Infants
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Tarnow-Mordi, William, Morris, Jonathan, Kirby, Adrienne, Robledo, Kristy, Askie, Lisa, Brown, Rebecca, Evans, Nicholas, Finlayson, Sarah, Fogarty, Michael, Gebski, Val, Ghadge, Alpana, Hague, Wendy, Isaacs, David, Jeffery, Michelle, Keech, Anthony, Kluckow, Martin, Popat, Himanshu, Sebastian, Lucille, Aagaard, Kjersti, Belfort, Michael, Pammi, Mohan, Abdel-Latif, Mohamed, Reynolds, Graham, Ariff, Shabina, Sheikh, Lumaan, Chen, Yan, Colditz, Paul, Liley, Helen, Pritchard, Margo, de Luca, Daniele, de Waal, Koert, Forder, Peta, Duley, Lelia, El-Naggar, Walid, Gill, Andrew, Newnham, John, Simmer, Karen, Groom, Katie, Weston, Philip, Gullam, Joanna, Patel, Harshad, Koh, Guan, Lui, Kei, Marlow, Neil, Morris, Scott, Sehgal, Arvind, Wallace, Euan, Soll, Roger, Young, Leslie, Sweet, David, Walker, Susan, Watkins, Andrew, Wright, Ian, Osborn, David, and Simes, John
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- 2017
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6. Effects of delayed versus immediate umbilical cord clamping in reducing death or major disability at 2 years corrected age among very preterm infants (APTS): a multicentre, randomised clinical trial
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Robledo, Kristy P, primary, Tarnow-Mordi, William O, additional, Rieger, Ingrid, additional, Suresh, Preeti, additional, Martin, Andrew, additional, Yeung, Carbo, additional, Ghadge, Alpana, additional, Liley, Helen G, additional, Osborn, David, additional, Morris, Jonathan, additional, Hague, Wendy, additional, Kluckow, Martin, additional, Lui, Kei, additional, Soll, Roger, additional, Cruz, Melinda, additional, Keech, Anthony, additional, Kirby, Adrienne, additional, Simes, John, additional, Popat, Himanshu, additional, Reid, Shelley, additional, Gordon, Adrienne, additional, De Waal, Koert, additional, Wright, Ian M, additional, Wright, Anne, additional, Buchan, Jane, additional, Stubbs, Michelle, additional, Newnham, John, additional, Simmer, Karen, additional, Young, Cherry, additional, Loh, Diane, additional, Kok, Yen, additional, Gill, Andy, additional, Strunk, Tobias, additional, Jeffery, Michele, additional, Chen, Yan, additional, Morris, Scott, additional, Sinhal, Sanjay, additional, Cornthwaite, Kathryn, additional, Walker, Sue P, additional, Watkins, Andrew M, additional, Collins, Clare L, additional, Holberton, James R, additional, Noble, Elizabeth J, additional, Sehgal, Arvind, additional, Yeomans, Emma, additional, Elsayed, Kristy, additional, Mohamed, Abdel-Latif, additional, Broom, Margaret, additional, Koh, Guan, additional, Lawrence, Annemarie, additional, Gardener, Glen, additional, Fox, Jane, additional, Cartwright, David W, additional, Koorts, Pieter, additional, Pritchard, Margo A, additional, McKeown, Lisa, additional, Lainchbury, Anne, additional, Shand, Antonia W, additional, Michalowski, Joanna, additional, Smyth, John P, additional, Bolisetty, Srinivas, additional, Adno, Alan, additional, Lee, Gaksoo, additional, Seidler, Anna L, additional, Askie, Lisa M, additional, Groom, Katie M, additional, Eaglen, Deborah A, additional, Baker, Ella C, additional, Patel, Harshad, additional, Wilkes, Natalie, additional, Gullam, Joanna E, additional, Austin, Nicola, additional, Leishman, Dianne E, additional, Weston, Phil, additional, White, Nicola, additional, Cooper, Nadia A, additional, Broadbent, Roland, additional, Stitely, Michael, additional, Dawson, Pauline, additional, El-Naggar, Walid, additional, Furlong, Marlene, additional, Hatfield, Tara, additional, de Luca, Daniele, additional, Benachi, Alexandra, additional, Letamendia-Richard, Emmanuelle, additional, Escourrou, Guillaume, additional, Dell'Orto, Valentina, additional, Sweet, David, additional, Millar, Muriel, additional, Shah, Shilpa, additional, Sheikh, Lumaan, additional, Ariff, Shabina, additional, Morris, Erin A, additional, Young, Leslie, additional, Evans, Shannon K, additional, Belfort, Michael, additional, Aagaard, Kjersti, additional, Pammi, Mohan, additional, Mandy, George, additional, Gandhi, Manisha, additional, Davey, Jane, additional, Shenton, Emma, additional, Middleton, Jennifer, additional, Black, Roslyn, additional, Cheng, Annie, additional, Murdoch, Jamie, additional, Jacobs, Claire, additional, Meyer, Lizzie, additional, Medlin, Kathryn, additional, Woods, Heather, additional, O'Connor, Kerry-Ann, additional, Bice, Caitlin, additional, Scott, Katherine, additional, Hayes, Marie, additional, Cruickshank, Debbie, additional, Sam, Mekha, additional, Ireland, Susan, additional, Dickinson, Corrine, additional, Poulsen, Leith, additional, Fucek, Andreja, additional, Hegarty, Jo, additional, Rogers, Jenny, additional, Sanchez, Dorothy, additional, Zupan Simunek, Veronique, additional, Hanif, Bakhtawar, additional, Pahl, Adrienne, additional, Metayer, Jerilyn, additional, Duley, Lelia, additional, Marlow, Neil, additional, Schofield, Deborah, additional, and Bowen, Jennifer, additional
- Published
- 2022
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7. The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial
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Tarnow-Mordi, William O, primary, Abdel-Latif, Mohamed E, additional, Martin, Andrew, additional, Pammi, Mohan, additional, Robledo, Kristy, additional, Manzoni, Paolo, additional, Osborn, David, additional, Lui, Kei, additional, Keech, Anthony, additional, Hague, Wendy, additional, Ghadge, Alpana, additional, Travadi, Javeed, additional, Brown, Rebecca, additional, Darlow, Brian A, additional, Liley, Helen, additional, Pritchard, Margo, additional, Kochar, Anu, additional, Isaacs, David, additional, Gordon, Adrienne, additional, Askie, Lisa, additional, Cruz, Melinda, additional, Schindler, Tim, additional, Dixon, Kelly, additional, Deshpande, Girish, additional, Tracy, Mark, additional, Schofield, Deborah, additional, Austin, Nicola, additional, Sinn, John, additional, Simes, R John, additional, Black, R., additional, Nie, W., additional, Reid, S., additional, Michalowski, J., additional, McKeown, L., additional, Koorts, P., additional, Broom, M., additional, Kwan, P., additional, Morris, S., additional, Cornthwaite, K., additional, Tobiansky, R., additional, Darcy, D., additional, Goodchild, L., additional, Collins, C., additional, Noble, E., additional, Lewis, A., additional, Yeomans, E., additional, Hua, C., additional, Hinder, M., additional, Bhaskaracharya, A., additional, Graham, P., additional, Patel, H., additional, Wilkes, N, additional, Marlow, N., additional, Soll, R., additional, McKinlay, C., additional, Modi, N., additional, Marschner, I., additional, Stenson, B., additional, and Espinoza, D., additional
- Published
- 2020
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8. Protocol for the Lactoferrin Infant Feeding Trial (LIFT): a randomised trial of adding lactoferrin to the feeds of very-low birthweight babies prior to hospital discharge
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Martin, Andrew, primary, Ghadge, Alpana, additional, Manzoni, Paolo, additional, Lui, Kei, additional, Brown, Rebecca, additional, and Tarnow-Mordi, William, additional
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- 2018
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9. Delayed versus Immediate Cord Clamping in Preterm Infants
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Tarnow-Mordi, William O, Morris, Jonathan, Kirby, Adrienne, Robledo, K, Askie, Lisa, Brown, Rebecca, Evans, Nicholas, Finlayson, Sarah, Fogarty, Michael, Gebski, Val, Ghadge, Alpana, Hague, Wendy, Isaacs, David, Jeffery, Michelle, Keech, Anthony, Kluckow, Martin, Popat, Himanshu, Sebastian, Lucille, Aagaard, Kjersti, Belfort, Michael, Pammi, Mohan, Abdel-Latif, Mohamed E, Reynolds, Graham, Ariff, Shabina, Sheikh, Lumaan, Chen, Yan, Colditz, Paul, Liley, Helen, Pritchard, Margo, De Luca, Daniele, de Waal, Koert, Forder, Peta, Duley, Lelia, El-Naggar, Walid, Gill, Andrew, Newnham, John, Simmer, Karen, Groom, Katie, Weston, Philip, Gullam, Joanna, Patel, Harshad, Koh, Guan, Lui, Kei, Marlow, Neil, Morris, Scott, Sehgal, Arvind, Wallace, Euan M, Soll, Roger, Young, Leslie, Sweet, David, Walker, Susan, Watkins, Andrew, Wright, Ian M. R, Osborn, David, Simes, John E, Tarnow-Mordi, William O, Morris, Jonathan, Kirby, Adrienne, Robledo, K, Askie, Lisa, Brown, Rebecca, Evans, Nicholas, Finlayson, Sarah, Fogarty, Michael, Gebski, Val, Ghadge, Alpana, Hague, Wendy, Isaacs, David, Jeffery, Michelle, Keech, Anthony, Kluckow, Martin, Popat, Himanshu, Sebastian, Lucille, Aagaard, Kjersti, Belfort, Michael, Pammi, Mohan, Abdel-Latif, Mohamed E, Reynolds, Graham, Ariff, Shabina, Sheikh, Lumaan, Chen, Yan, Colditz, Paul, Liley, Helen, Pritchard, Margo, De Luca, Daniele, de Waal, Koert, Forder, Peta, Duley, Lelia, El-Naggar, Walid, Gill, Andrew, Newnham, John, Simmer, Karen, Groom, Katie, Weston, Philip, Gullam, Joanna, Patel, Harshad, Koh, Guan, Lui, Kei, Marlow, Neil, Morris, Scott, Sehgal, Arvind, Wallace, Euan M, Soll, Roger, Young, Leslie, Sweet, David, Walker, Susan, Watkins, Andrew, Wright, Ian M. R, Osborn, David, and Simes, John E
- Abstract
BACKGROUND The preferred timing of umbilical-cord clamping in preterm infants is unclear. METHODS We randomly assigned fetuses from women who were expected to deliver before 30 weeks of gestation to either immediate clamping of the umbilical cord (=10 seconds after delivery) or delayed clamping (=60 seconds after delivery). The primary composite outcome was death or major morbidity (defined as severe brain injury on postnatal ultrasonography, severe retinopathy of prematurity, necrotizing enterocolitis, or late-onset sepsis) by 36 weeks of postmenstrual age. Analyses were performed on an intention-to-treat basis, accounting for multiple births. RESULTS Of 1634 fetuses that underwent randomization, 1566 were born alive before 30 weeks of gestation; of these, 782 were assigned to immediate cord clamping and 784 to delayed cord clamping. The median time between delivery and cord clamping was 5 seconds and 60 seconds in the respective groups. Complete data on the primary outcome were available for 1497 infants (95.6%). There was no significant difference in the incidence of the primary outcome between infants assigned to delayed clamping (37.0%) and those assigned to immediate clamping (37.2%) (relative risk, 1.00; 95% confidence interval, 0.88 to 1.13; P=0.96). The mortality was 6.4% in the delayed-clamping group and 9.0% in the immediate-clamping group (P=0.03 in unadjusted analyses; P=0.39 after post hoc adjustment for multiple secondary outcomes). There were no significant differences between the two groups in the incidences of chronic lung disease or other major morbidities. CONCLUSIONS Among preterm infants, delayed cord clamping did not result in a lower incidence of the combined outcome of death or major morbidity at 36 weeks of gestation than immediate cord clamping.
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- 2017
10. Outcomes of two trials of oxygen-saturation targets in preterm infants
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Tarnow-Mordi, William O, Stenson, Ben, Kirby, Adrienne, Juszczak, Edmund, Donoghoe, Mark, Deshpande, Sanjeev, Morley, Colin J, King, Andrew, Doyle, Lex W, Fleck, Brian W, Davis, Peter, Halliday, Henry L, Hague, Wendy, Cairns, Pamela, Darlow, Brian A, Fielder, Alistair R, Gebski, Val, Marlow, Neil, Simmer, Karen, Tin, Win, Ghadge, Alpana, Williams, Cathy, Keech, Anthony, Wardle, Stephen P, Kecskes, Zsuzsoka, Kluckow, Martin, Gole, Glen, Evans, Nicholas, Malcolm, Girvan, Luig, Melissa, Wright, Ian M. R, Stack, Jacqueline, Tan, Kenneth, Pritchard, Margo, Gray, Peter H, Morris, Scott, Headley, Bevan, Dargaville, Peter, Simes, R John, Brocklehurst, Peter, Tarnow-Mordi, William O, Stenson, Ben, Kirby, Adrienne, Juszczak, Edmund, Donoghoe, Mark, Deshpande, Sanjeev, Morley, Colin J, King, Andrew, Doyle, Lex W, Fleck, Brian W, Davis, Peter, Halliday, Henry L, Hague, Wendy, Cairns, Pamela, Darlow, Brian A, Fielder, Alistair R, Gebski, Val, Marlow, Neil, Simmer, Karen, Tin, Win, Ghadge, Alpana, Williams, Cathy, Keech, Anthony, Wardle, Stephen P, Kecskes, Zsuzsoka, Kluckow, Martin, Gole, Glen, Evans, Nicholas, Malcolm, Girvan, Luig, Melissa, Wright, Ian M. R, Stack, Jacqueline, Tan, Kenneth, Pritchard, Margo, Gray, Peter H, Morris, Scott, Headley, Bevan, Dargaville, Peter, Simes, R John, and Brocklehurst, Peter
- Abstract
BACKGROUND The safest ranges of oxygen saturation in preterm infants have been the subject of debate. METHODS In two trials, conducted in Australia and the United Kingdom, infants born before 28 weeks' gestation were randomly assigned to either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range. During enrollment, the oximeters were revised to correct a calibration-algorithm artifact. The primary outcome was death or disability at a corrected gestational age of 2 years; this outcome was evaluated among infants whose oxygen saturation was measured with any study oximeter in the Australian trial and those whose oxygen saturation was measured with a revised oximeter in the U.K. trial. RESULTS After 1135 infants in Australia and 973 infants in the United Kingdom had been enrolled in the trial, an interim analysis showed increased mortality at a corrected gestational age of 36 weeks, and enrollment was stopped. Death or disability in the Australian trial (with all oximeters included) occurred in 247 of 549 infants (45.0%) in the lower-target group versus 217 of 545 infants (39.8%) in the higher-target group (adjusted relative risk, 1.12; 95% confidence interval [CI], 0.98 to 1.27; P = 0.10); death or disability in the U.K. trial (with only revised oximeters included) occurred in 185 of 366 infants (50.5%) in the lower-target group versus 164 of 357 infants (45.9%) in the higher-target group (adjusted relative risk, 1.10; 95% CI, 0.97 to 1.24; P = 0.15). In post hoc combined, unadjusted analyses that included all oximeters, death or disability occurred in 492 of 1022 infants (48.1%) in the lower-target group versus 437 of 1013 infants (43.1%) in the higher-target group (relative risk, 1.11; 95% CI, 1.01 to 1.23; P = 0.02), and death occurred in 222 of 1045 infants (21.2%) in the lower-target group versus 185 of 1045 infants (17.7%) in the higher-target group (relative risk, 1.20; 95% CI, 1.01 to 1.43; P = 0.04). In the group in which revised oximeters wer
- Published
- 2016
11. Clinicians in 25 countries prefer to use lower levels of oxygen to resuscitate preterm infants at birth
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Oei, Ju Lee, Ghadge, Alpana, Coates, Elisabeth, Wright, Ian M. R, Saugstad, Ola, Vento, Maximo, Buonocore, Giuseppe, Nagashima, Tatsuo, Suzuki, Keiji, Hosono, Shiguhero, Davis, Peter, Graven, Paul, Askie, Lisa, Dawson, Jennifer, Garg, Shalabh, Keech, Anthony, Rabi, Yacov, Smyth, John, Sinha, Sunil, Stenson, Ben, Liu, Kei, Hunter, Carol Lu, Tarnow-Mordi, William O, Oei, Ju Lee, Ghadge, Alpana, Coates, Elisabeth, Wright, Ian M. R, Saugstad, Ola, Vento, Maximo, Buonocore, Giuseppe, Nagashima, Tatsuo, Suzuki, Keiji, Hosono, Shiguhero, Davis, Peter, Graven, Paul, Askie, Lisa, Dawson, Jennifer, Garg, Shalabh, Keech, Anthony, Rabi, Yacov, Smyth, John, Sinha, Sunil, Stenson, Ben, Liu, Kei, Hunter, Carol Lu, and Tarnow-Mordi, William O
- Abstract
Aim This study determined current international clinical practice and opinions regarding initial fractional inspired oxygen (FiO2) and pulse oximetry (SpO2) targets for delivery room resuscitation of preterm infants of less than 29 weeks of gestation. Methods An online survey was disseminated to neonatal clinicians via established professional clinical networks using a web-based survey programme between March 9 and June 30, 2015. Results Of the 630 responses from 25 countries, 60% were from neonatologists. The majority (77%) would target SpO2 between the 10th to 50th percentiles values for full-term infants. The median starting FiO2 was 0.3, with Japan using the highest (0.4) and the UK using the lowest (0.21). New Zealand targeted the highest SpO2 percentiles (median 50%). Most respondents agreed or did not disagree that a trial was required that compared the higher FiO2 of 0.6 (83%), targeting the 50th SpO2 percentile (60%), and the lower FiO2 of 0.21 (80%), targeting the 10th SpO2 percentile (78%). Most (65%) would join this trial. Many considered that evidence was lacking and further research was needed. Conclusion Clinicians currently favour lower SpO2 targets for preterm resuscitation, despite acknowledging the lack of evidence for benefit or harm, and 65% would join a clinical trial.
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- 2016
12. Clinicians in 25 countries prefer to use lower levels of oxygen to resuscitate preterm infants at birth.
- Author
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Oei JL, Ghadge A, Coates E, Wright IM, Saugstad OD, Vento M, Buonocore G, Nagashima T, Suzuki K, Hosono S, Davis PG, Craven P, Askie L, Dawson J, Garg S, Keech A, Rabi Y, Smyth J, Sinha S, Stenson B, Lui K, Hunter CL, and Tarnow Mordi W
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- Humans, Infant, Newborn, Infant, Premature, Surveys and Questionnaires, Asphyxia Neonatorum therapy, Neonatologists statistics & numerical data, Oxygen administration & dosage, Resuscitation
- Abstract
Aim: This study determined current international clinical practice and opinions regarding initial fractional inspired oxygen (FiO2 ) and pulse oximetry (SpO2 ) targets for delivery room resuscitation of preterm infants of less than 29 weeks of gestation., Methods: An online survey was disseminated to neonatal clinicians via established professional clinical networks using a web-based survey programme between March 9 and June 30, 2015., Results: Of the 630 responses from 25 countries, 60% were from neonatologists. The majority (77%) would target SpO2 between the 10th to 50th percentiles values for full-term infants. The median starting FiO2 was 0.3, with Japan using the highest (0.4) and the UK using the lowest (0.21). New Zealand targeted the highest SpO2 percentiles (median 50%). Most respondents agreed or did not disagree that a trial was required that compared the higher FiO2 of 0.6 (83%), targeting the 50th SpO2 percentile (60%), and the lower FiO2 of 0.21 (80%), targeting the 10th SpO2 percentile (78%). Most (65%) would join this trial. Many considered that evidence was lacking and further research was needed., Conclusion: Clinicians currently favour lower SpO2 targets for preterm resuscitation, despite acknowledging the lack of evidence for benefit or harm, and 65% would join a clinical trial., (©2016 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.)
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- 2016
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13. Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants.
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Tarnow-Mordi W, Stenson B, Kirby A, Juszczak E, Donoghoe M, Deshpande S, Morley C, King A, Doyle LW, Fleck BW, Davis PG, Halliday HL, Hague W, Cairns P, Darlow BA, Fielder AR, Gebski V, Marlow N, Simmer K, Tin W, Ghadge A, Williams C, Keech A, Wardle SP, Kecskes Z, Kluckow M, Gole G, Evans N, Malcolm G, Luig M, Wright I, Stack J, Tan K, Pritchard M, Gray PH, Morris S, Headley B, Dargaville P, Simes RJ, and Brocklehurst P
- Subjects
- Australia, Child, Preschool, Female, Humans, Infant, Infant, Newborn, Male, Oximetry, Oxygen Inhalation Therapy adverse effects, Risk, United Kingdom, Developmental Disabilities epidemiology, Infant Mortality, Infant, Extremely Premature blood, Oxygen blood, Oxygen Inhalation Therapy methods
- Abstract
Background: The safest ranges of oxygen saturation in preterm infants have been the subject of debate., Methods: In two trials, conducted in Australia and the United Kingdom, infants born before 28 weeks' gestation were randomly assigned to either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range. During enrollment, the oximeters were revised to correct a calibration-algorithm artifact. The primary outcome was death or disability at a corrected gestational age of 2 years; this outcome was evaluated among infants whose oxygen saturation was measured with any study oximeter in the Australian trial and those whose oxygen saturation was measured with a revised oximeter in the U.K. trial., Results: After 1135 infants in Australia and 973 infants in the United Kingdom had been enrolled in the trial, an interim analysis showed increased mortality at a corrected gestational age of 36 weeks, and enrollment was stopped. Death or disability in the Australian trial (with all oximeters included) occurred in 247 of 549 infants (45.0%) in the lower-target group versus 217 of 545 infants (39.8%) in the higher-target group (adjusted relative risk, 1.12; 95% confidence interval [CI], 0.98 to 1.27; P=0.10); death or disability in the U.K. trial (with only revised oximeters included) occurred in 185 of 366 infants (50.5%) in the lower-target group versus 164 of 357 infants (45.9%) in the higher-target group (adjusted relative risk, 1.10; 95% CI, 0.97 to 1.24; P=0.15). In post hoc combined, unadjusted analyses that included all oximeters, death or disability occurred in 492 of 1022 infants (48.1%) in the lower-target group versus 437 of 1013 infants (43.1%) in the higher-target group (relative risk, 1.11; 95% CI, 1.01 to 1.23; P=0.02), and death occurred in 222 of 1045 infants (21.2%) in the lower-target group versus 185 of 1045 infants (17.7%) in the higher-target group (relative risk, 1.20; 95% CI, 1.01 to 1.43; P=0.04). In the group in which revised oximeters were used, death or disability occurred in 287 of 580 infants (49.5%) in the lower-target group versus 248 of 563 infants (44.0%) in the higher-target group (relative risk, 1.12; 95% CI, 0.99 to 1.27; P=0.07), and death occurred in 144 of 587 infants (24.5%) versus 99 of 586 infants (16.9%) (relative risk, 1.45; 95% CI, 1.16 to 1.82; P=0.001)., Conclusions: Use of an oxygen-saturation target range of 85 to 89% versus 91 to 95% resulted in nonsignificantly higher rates of death or disability at 2 years in each trial but in significantly increased risks of this combined outcome and of death alone in post hoc combined analyses. (Funded by the Australian National Health and Medical Research Council and others; BOOST-II Current Controlled Trials number, ISRCTN00842661, and Australian New Zealand Clinical Trials Registry number, ACTRN12605000055606.).
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- 2016
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14. Oxygen saturation and outcomes in preterm infants.
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Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, and Brocklehurst P
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- Algorithms, Calibration, Cerebral Hemorrhage epidemiology, Enterocolitis, Necrotizing epidemiology, Female, Hospital Mortality, Humans, Infant Mortality, Infant, Newborn, Infant, Premature, Diseases epidemiology, Male, Oximetry, Oxygen Inhalation Therapy adverse effects, Retinopathy of Prematurity etiology, Infant, Extremely Premature blood, Infant, Premature, Diseases mortality, Oxygen blood, Oxygen Inhalation Therapy methods, Retinopathy of Prematurity prevention & control
- Abstract
Background: The clinically appropriate range for oxygen saturation in preterm infants is unknown. Previous studies have shown that infants had reduced rates of retinopathy of prematurity when lower targets of oxygen saturation were used., Methods: In three international randomized, controlled trials, we evaluated the effects of targeting an oxygen saturation of 85 to 89%, as compared with a range of 91 to 95%, on disability-free survival at 2 years in infants born before 28 weeks' gestation. Halfway through the trials, the oximeter-calibration algorithm was revised. Recruitment was stopped early when an interim analysis showed an increased rate of death at 36 weeks in the group with a lower oxygen saturation. We analyzed pooled data from patients and now report hospital-discharge outcomes., Results: A total of 2448 infants were recruited. Among the 1187 infants whose treatment used the revised oximeter-calibration algorithm, the rate of death was significantly higher in the lower-target group than in the higher-target group (23.1% vs. 15.9%; relative risk in the lower-target group, 1.45; 95% confidence interval [CI], 1.15 to 1.84; P=0.002). There was heterogeneity for mortality between the original algorithm and the revised algorithm (P=0.006) but not for other outcomes. In all 2448 infants, those in the lower-target group for oxygen saturation had a reduced rate of retinopathy of prematurity (10.6% vs. 13.5%; relative risk, 0.79; 95% CI, 0.63 to 1.00; P=0.045) and an increased rate of necrotizing enterocolitis (10.4% vs. 8.0%; relative risk, 1.31; 95% CI, 1.02 to 1.68; P=0.04). There were no significant between-group differences in rates of other outcomes or adverse events., Conclusions: Targeting an oxygen saturation below 90% with the use of current oximeters in extremely preterm infants was associated with an increased risk of death. (Funded by the Australian National Health and Medical Research Council and others; BOOST II Current Controlled Trials number, ISRCTN00842661, and Australian New Zealand Clinical Trials Registry numbers, ACTRN12605000055606 and ACTRN12605000253606.).
- Published
- 2013
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