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1. Personalising Outcomes after Child Cardiac Arrest (POCCA): design and recruitment challenges of a multicentre, observational study

Author

Elizabeth Hunt, Katie Smith, Neha Patel, Ericka L Fink, Robert S B Clark, Ashok Panigrahy, Rachel Berger, Jessica Wisnowski, Stefan Bluml, David Maloney, Pamela Rubin, Tamara Haller, Hulya Bayir, Sue R Beers, Patrick M Kochanek, Anthony Fabio, Patrick Kochanek, Robert Clark, Sue Beers, Tony Fabio, Karen Walson, Alexis Topjian, Christopher JL Newth, Jordan Duval-Arnould, Binod Balakrishnan, Michael T Meyer, Melissa G Chung, Anthony Willyerd, Lincoln Smith, Jesse Wenger, Stuart Friess, Jose Pineda, Ashley Siems, Jason Patregnani, John Diddle, Aline Maddux, Lesley Doughty, Juan Piantino, Beena Desai, Maureen G Richardson, Cynthia Bates, Darshana Parikh, Janice Prodell, Maddie Winters, Jeni Kwok, Adriana Cabrales, Ronke Adewale, Pam Melvin, Sadaf Shad, Katherine Siegel, Katherine Murkowski, Mary Kasch, Josey Hensley, Lisa Steele, Danielle Brown, Brian Burrows, Lauren Hlivka, Deana Rich, Amila Tutundzic, Tina Day, Lori Barganier, Ashley Wolfe, Mackenzie Little, Elyse Tomanio, Diane Hession, Yamila Sierra, Ruth Grosskreuz, BS Kevin Van, Rhonda Jones, Laura Benken, Beata Dyar, Laura Mishler, Jonathan Elmer, Subramanian Subramanian, Julia Wallace, Tami Robinson, Andrew Frank, Keri Feldman, Avinash Vemulapalli, Linda Ryan, Scott Szypulski, and Christopher Keys

Subjects
Medicine
Abstract

Introduction Blood and imaging biomarkers show promise in prognosticating outcomes after paediatric cardiac arrest in pilot studies. We describe the methods and early recruitment challenges and solutions for an ongoing multicentre (n=14) observational trial, Personalising Outcomes following Child Cardiac Arrest to validate clinical, blood and imaging biomarkers individually and together in a clinically relevant panel.Methods and analysis Children (n=164) between 48 hours and 17 years of age who receive chest compressions irrespective of provider, duration, or event location and are admitted to an intensive care unit are eligible. Blood samples will be taken on days 1–3 for the measurement of brain-focused biomarkers analysed to predict the outcome. Clinically indicated and timed brain MRI and spectroscopy biomarkers will be analysed to predict the outcome. The primary outcome for the trial is survival with favourable (Vineland Adaptive Behavioural Scale score >70) outcome at 1 year. Secondary outcomes include mortality and pre-event and postdischarge measures of emotional, cognitive, physical and family functioning and health-related quality of life. Early enrollment targets were not met due to prolonged regulatory and subcontract processes. Multiple, simultaneous interventions including modification to inclusion criteria, additional sites and site visits were implemented with successful improvement in recruitment. Study procedures including outcomes and biomarker analysis are ongoing.Ethics and dissemination Twelve of 14 sites will use the centralised Institutional Review Board (IRB) at the University of Pittsburgh (PRO14030712). Two sites will use individual IRBs: Children’s Healthcare of Atlanta Institutional Review Board and Children’s Hospital of Wisconsin IRB. Parents and/or guardians are consented and children assented (when possible) by the site Primary investigator (PI) or research coordinator for enrollment. Study findings will be disseminated through scientific conferences, peer-reviewed journal publications, public study website materials and invited lectures.Trial registration number NCT02769026.

Published
2020
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2. Natural history of pediatric intestinal failure: initial report from the Pediatric Intestinal Failure Consortium

Author

Robert H, Squires, Christopher, Duggan, Daniel H, Teitelbaum, Paul W, Wales, Jane, Balint, Robert, Venick, Susan, Rhee, Debra, Sudan, David, Mercer, J Andres, Martinez, Beth A, Carter, Jason, Soden, Simon, Horslen, Jeffrey A, Rudolph, Samuel, Kocoshis, Riccardo, Superina, Sharon, Lawlor, Tamara, Haller, Marcia, Kurs-Lasky, Steven H, Belle, and Conrad, Cole

Subjects
Male, medicine.medical_specialty, Pediatrics, Parenteral Nutrition, Intestinal Atresia, Gastroenterology, Enteral administration, Article, Enterocolitis, Necrotizing, Internal medicine, medicine, Humans, Hirschsprung Disease, Retrospective Studies, Gastroschisis, business.industry, Intestinal atresia, Gestational age, Infant, Retrospective cohort study, medicine.disease, Prognosis, Transplantation, Intestines, Intestinal Diseases, Parenteral nutrition, Pediatrics, Perinatology and Child Health, Cohort, Necrotizing enterocolitis, Female, business, Intestinal Volvulus
Abstract

Objective To characterize the natural history of intestinal failure (IF) among 14 pediatric centers during the intestinal transplantation era. Study design The Pediatric Intestinal Failure Consortium performed a retrospective analysis of clinical and outcome data for a multicenter cohort of infants with IF. Entry criteria included infants 60 continuous days. Enteral autonomy was defined as discontinuation of PN for >3 consecutive months. Values are presented as median (25th, 75th percentiles) or as number (%). Results 272 infants with a gestational age of 34 weeks (30, 36) and birth weight of 2.1 kg (1.2, 2.7) were followed for 25.7 months (11.2, 40.9). Residual small bowel length in 144 patients was 41 cm (25.0, 65.5). Diagnoses were necrotizing enterocolitis (71, 26%), gastroschisis (44, 16%), atresia (27, 10%), volvulus (24, 9%), combinations of these diagnoses (46, 17%), aganglionosis (11, 4%), and other single or multiple diagnoses (48, 18%). Prescribed medications included oral antibiotics (207, 76%), H2 blockers (187, 69%), and proton pump inhibitors (156, 57%). Enteral feeding approaches varied among centers; 19% of the cohort received human milk. The cohort experienced 8.9 new catheter-related blood stream infections per 1000 catheter days. The cumulative incidences for enteral autonomy, death, and intestinal transplantation were 47%, 27%, and 26%, respectively. Enteral autonomy continued into the fifth year after study entry. Conclusions Children with IF endure significant mortality and morbidity. Enteral autonomy may require years to achieve. Improved medical, nutritional, and surgical management may reduce time on PN, mortality, and need for transplantation.

Published
2012

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