SynthesisJAMA network open2024
Eligible Infants Included in Neonatal Clinical Trials and Reasons for Noninclusion: A Systematic Review.
Synthesis in JAMA network open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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.
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.
Who cites it
12 citing papers in PubMed.
- Determinants of Infant Participation and Non-Participation in Primary Prevention Trials.Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2026Trial
- A quality improvement project to optimize the neonatology research experience for families.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Therapeutic hypothermia at 35 weeks' gestation: navigating controversy between randomized evidence, real-world practice, and shared decision-making.Pediatric research · 2026Article
- Parental Consent to a Neonatal Clinical Study: The Roles of Uncertainty, Burden of Sample Collection and Societal Expectations.Acta paediatrica (Oslo, Norway : 1992) · 2026Article
- Neonatology: First Exposure to Antibiotics from the Ethical Perspective of Parents, Physicians, and Regulators.Antibiotics (Basel, Switzerland) · 2025Article
- Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): A Feasibility Randomized Controlled Trial.Children (Basel, Switzerland) · 2025Article
- The Role of Mesenchymal Stromal Cells in the Treatment of Bronchopulmonary Dysplasia: A Multi-Prong Approach for a Heterogeneous Disease.Comprehensive Physiology · 2025Review
- Childhood Differences in Healthcare Utilization Between Extremely Preterm Infants and the General Population.Children (Basel, Switzerland) · 2025Article
- Updated Size at Birth Charts for South Indian Neonates: Correspondence.Indian journal of pediatrics · 2025Article
- Piloting the better research interactions for every family (BRIEF) researcher intervention to support recruitment for a neonatal clinical trial: parent experience and infant enrollment.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Towards better enrollment decision-making for perinatal clinical research: Reconsidering recruitment and consent processes to support family values and preferences.Seminars in perinatology · 2025Review
- Partial waiver of consent to overcome translational science barriers in neonatal clinical research.Journal of clinical and translational science · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Importance: Results of clinical trials can only represent included participants, and many neonatal trials fail due to insufficient participation. Infants not included in research may differ from those included in meaningful ways, biasing the sample and limiting the generalizability of findings. Objective: To describe the proportion of eligible infants included in neonatal clinical trials and the reasons for noninclusion. Evidence Review: A systematic search of Cochrane CENTRAL was performed by retrieving articles meeting the following inclusion criteria: full-length, peer-reviewed articles describing clinical trial results in at least 20 human infants from US neonatal intensive care units, published in English, and added to Cochrane CENTRAL between 2017 and 2022. Retrieved articles were screened for inclusion by 2 independent researchers. Findings: In total 120 articles met inclusion criteria and 91 of these (75.8%) reported the number of infants eligible for participation, which totaled 26 854 in aggregate. Drawing from these, an aggregate of 11 924 eligible infants (44.4%) were included in reported results. Among all eligible infants, most reasons for noninclusion in results were classified as modifiable or potentially modifiable by the research team. Parents declining to participate (8004 infants [29.8%]) or never being approached (2507 infants [9.3%]) were the 2 predominant reasons for noninclusion. Other modifiable reasons included factors related to study logistics, such as failure to appropriately collect data on enrolled infants (859 of 26 854 infants [3.2%]) and other reasons (1907 of 26 854 infants [7.1%]), such as loss to follow-up or eligible participants that were unaccounted for. Nonmodifiable reasons, including clinical change or death, accounted for a small proportion of eligible infants who were not included (858 of 26 854 infants [3.2%]). Conclusions and Relevance: This systematic review of reporting on eligible infants included and not included in neonatal clinical trials highlights the need for improved documentation on the flow of eligible infants through neonatal clinical trials and may also inform recruitment expectations for trialists designing future protocols. Improved adherence to standardized reporting may clarify which potential participants are being missed, improving understanding of the generalizability of research findings. Furthermore, these findings suggest that future work to understand why parents decline to participate in neonatal research trials and why some are never approached about research may help increase overall participation.
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Registered trials
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.