Evidence map›Paper›PMID 33894262›Full record

SynthesisThe Journal of pediatrics2021

Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.

Leeann R Pavlek, Brian K Rivera, Charles V Smith, Joanie Randle, Cory Hanlon, Kristi Small, Edward F Bell, Matthew A Rysavy, Sara Conroy, Carl H Backes

Abstract readSystematic Review
In one paragraph

Synthesis in The Journal of pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Infants ≤24 weeks are not just smaller extremely preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2026
    Review
  2. Article
  3. Review
  4. It's the little things. A framework and guidance for programs to care for infants 22-23 weeks' gestational age.Journal of perinatology : official journal of the California Perinatal Association · 2025
    Review
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Leeann R PavlekCenter 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.
Brian K RiveraCenter for Perinatal Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH.
Charles V SmithCenter for Integrated Brain Research, Seattle Children's Research Institute, Seattle, WA.
Joanie RandleOhio Perinatal Research Network at Nationwide Children's Hospital, Columbus, OH.
Cory HanlonOhio Perinatal Research Network at Nationwide Children's Hospital, Columbus, OH.
Kristi SmallOhio Perinatal Research Network at Nationwide Children's Hospital, Columbus, OH.
Edward F BellStead Family Department of Pediatrics, University of Iowa, Iowa City, IA.
Matthew A RysavyStead Family Department of Pediatrics, University of Iowa, Iowa City, IA.
Sara ConroyCenter for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, OH; Biostatistics Resource at Nationwide Children's Hospital, Columbus, OH.
Carl H BackesCenter 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.

Funding

NICHD NIH HHS L40 HD099827
6 · The paper itself

Abstract

objectiveTo 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

designPubMed 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.

resultsAmong 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.

conclusionsThe 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.

Indexed as

Infant, Extremely PrematurePatient SelectionRandomized Controlled Trials as TopicHumansInfant, Newbornexclusion criteriainclusion criteriapremature infant

Identifiers

PMID33894262
PMCPMC9348995

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.