Leeann R Pavlek1, Brian K Rivera2, Charles V Smith3, Joanie Randle4, Cory Hanlon4, Kristi Small4, Edward F Bell5, Matthew A Rysavy5, Sara Conroy6, Carl H Backes7. 1. Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH; Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH. 2. Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH. 3. Center for Integrated Brain Research, Seattle Children's Research Institute, Seattle, WA. 4. Ohio Perinatal Research Network at Nationwide Children's Hospital, Columbus, OH. 5. Stead Family Department of Pediatrics, University of Iowa, Iowa City, IA. 6. Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, OH; Biostatistics Resource at Nationwide Children's Hospital, Columbus, OH. 7. Center for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH; Department of Pediatrics, The Ohio State University Wexner Medical Center, Columbus, OH; Ohio Perinatal Research Network at Nationwide Children's Hospital, Columbus, OH; Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH; The Heart Center, Nationwide Children's Hospital, Columbus, OH. Electronic address: Carl.backesjr@nationwidechildrens.org.
Abstract
OBJECTIVE: To assess the eligibility criteria and trial characteristics among contemporary (2010-2019) randomized clinical trials (RCTs) that included infants born extremely preterm (<28 weeks of gestation) and to evaluate whether eligibility criteria result in underrepresentation of high-risk subgroups (eg, infants born at <24 weeks of gestation). STUDY DESIGN: PubMed and Scopus were searched January 1, 2010, to December 31, 2019, with no language restrictions. RCTs with mean or median gestational ages at birth of <28 weeks of gestation were included. The study followed the PRISMA guidelines; outcomes were registered prospectively. Data extraction was performed independently by multiple observers. Study quality was evaluated using a modified Jadad scale. RESULTS: Among RCTs (n = 201), 32 552 infants were included. Study participant characteristics, interventions, and outcomes were highly variable. A total of 1603 eligibility criteria were identified; rationales were provided for 18.8% (n = 301) of criteria. Fifty-five RCTs (27.4%) included infants <24 weeks of gestation; 454 (1.4%) infants were identified as <24 weeks of gestation. CONCLUSIONS: The present study identifies sources of variability across RCTs that included infants born extremely preterm and reinforces the critical need for consistent and transparent policies governing eligibility criteria.
OBJECTIVE: To assess the eligibility criteria and trial characteristics among contemporary (2010-2019) randomized clinical trials (RCTs) that included infants born extremely preterm (<28 weeks of gestation) and to evaluate whether eligibility criteria result in underrepresentation of high-risk subgroups (eg, infants born at <24 weeks of gestation). STUDY DESIGN: PubMed and Scopus were searched January 1, 2010, to December 31, 2019, with no language restrictions. RCTs with mean or median gestational ages at birth of <28 weeks of gestation were included. The study followed the PRISMA guidelines; outcomes were registered prospectively. Data extraction was performed independently by multiple observers. Study quality was evaluated using a modified Jadad scale. RESULTS: Among RCTs (n = 201), 32 552 infants were included. Study participant characteristics, interventions, and outcomes were highly variable. A total of 1603 eligibility criteria were identified; rationales were provided for 18.8% (n = 301) of criteria. Fifty-five RCTs (27.4%) included infants <24 weeks of gestation; 454 (1.4%) infants were identified as <24 weeks of gestation. CONCLUSIONS: The present study identifies sources of variability across RCTs that included infants born extremely preterm and reinforces the critical need for consistent and transparent policies governing eligibility criteria.
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