Journal article
Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants
Journal of perinatology : official journal of the California Perinatal Association, Vol.37(11), pp.1220-1223
09/01/2017
DOI: 10.1038/jp.2017.131
PMCID: PMC5688018
PMID: 28880260
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, <72° old, mechanically ventilated, receiving inotrope. Primary outcome was NDI at 2 years; infants with diagnoses at high risk for NDI were excluded. This paper presents an analysis of reasons for low patient enrollment. Result 257 of 932 otherwise eligible infants received inotropes; however, 207(81%) had exclusionary diagnoses. Only 12 infants were randomized over 10 months; therefore, the study was terminated. Contributing factors included few eligible infants after exclusions, open-label steroid therapy, and a narrow enrollment window. Conclusion Despite an observational study to estimate the population, very few infants were enrolled. Successful RCTs of emergent therapy may require fewer exclusions, a short-term primary outcome, waiver of consent, and/or other alternatives. Clinical trial registration Clinicaltrials.gov, NCT01954056
Details
- Title: Subtitle
- Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants
- Creators
- Kristi L. Watterberg - University of New MexicoErika Fernandez - University of New MexicoMichele C. Walsh - Rainbow Babies & Children's HospitalWilliam E. Truog - Children's Mercy HospitalBarbara J. Stoll - Emory UniversityGregory M. Sokol - Indiana UniversityKathleen A. Kennedy - The University of Texas Health Science Center at HoustonMaria V. Fraga - University of PennsylvaniaSandra Sundquist BeaumanBenjamin Carper - Environmental Protection AgencyAbhik Das - RTI InternationalAndrea Freeman Duncan - The University of Texas Health Science Center at HoustonWilliam F. Buss - Indiana University HealthCheri Gauldin - Children's Mercy HospitalConra Backstrom Lacy - University of New MexicoPablo J. Sanchez - Nationwide Children's HospitalSanjay Chawla - Wayne State UniversitySatyan Lakshminrusimha - Women & Children's Hospital of BuffaloC. Michael Cotten - Duke UniversityKrisa P. MeursBrenda B. Poindexter - Cincinnati Children's Hospital Medical CenterEdward F. Bell - University of IowaWaldemar A. Carlo - University of Alabama at BirminghamUday Devaskar - University of California, Los AngelesMyra H. Wyckoff - The University of Texas Southwestern Medical CenterRosemary D. Higgins - National Institutes of HealthEunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
- Resource Type
- Journal article
- Publication Details
- Journal of perinatology : official journal of the California Perinatal Association, Vol.37(11), pp.1220-1223
- DOI
- 10.1038/jp.2017.131
- PMID
- 28880260
- PMCID
- PMC5688018
- NLM abbreviation
- J Perinatol
- ISSN
- 0743-8346
- eISSN
- 1476-5543
- Language
- English
- Date published
- 09/01/2017
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology
- Record Identifier
- 9984353829102771
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