1. Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants
- Author
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Abhik Das, Sandy Sundquist Beauman, Barbara J. Stoll, William E Truog, B. Carper, Erika Fernandez, Myra H. Wyckoff, Satyanarayana Lakshminrusimha, Gregory M Sokol, Waldemar A. Carlo, Brenda B. Poindexter, Kathleen A. Kennedy, Pablo J. Sánchez, Sanjay Chawla, Cheri Gauldin, Rosemary D. Higgins, C M Cotten, K. P. Van Meurs, Edward F. Bell, W. F. Buss, Uday Devaskar, M.C. Walsh, María V. Fraga, Andrea F. Duncan, Conra Backstrom Lacy, and Kristi L. Watterberg
- Subjects
Inotrope ,Pediatrics ,Hydrocortisone ,Reproductive health and childbirth ,Low Birth Weight and Health of the Newborn ,law.invention ,Congenital ,0302 clinical medicine ,Randomized controlled trial ,law ,Informed consent ,Infant Mortality ,030212 general & internal medicine ,Heart Defects ,Pediatric ,education.field_of_study ,Informed Consent ,Obstetrics and Gynecology ,Early Termination of Clinical Trials ,Gestation ,Infant, Premature ,medicine.drug ,Heart Defects, Congenital ,medicine.medical_specialty ,Cardiotonic Agents ,Critical Illness ,Clinical Trials and Supportive Activities ,Population ,Clinical Sciences ,MEDLINE ,Article ,Paediatrics and Reproductive Medicine ,03 medical and health sciences ,Double-Blind Method ,Clinical Research ,Preterm ,030225 pediatrics ,medicine ,Humans ,education ,Premature ,Heart Failure ,business.industry ,Patient Selection ,Infant, Newborn ,Infant ,Perinatal Period - Conditions Originating in Perinatal Period ,Newborn ,Good Health and Well Being ,Neurodevelopmental Disorders ,Pediatrics, Perinatology and Child Health ,Observational study ,business - Abstract
Objective To analyze reasons for low enrollment in an RCT of the effect of hydrocortisone for cardiovascular insufficiency on survival without neurodevelopmental impairment (NDI) in term/late-preterm newborns. Study Design The original study was a multicenter RCT. Eligibility: ≥34 weeks’ gestation
- Published
- 2017