Evidence map›Paper›PMID 39653500›Full record

SynthesisArchives of disease in childhood. Fetal and neonatal edition2025

We should do better in accounting for multiple births in neonatal randomised trials: a methodological systematic review.

Kristy P Robledo, Sol Libesman, Lisa Nicole Yelland

Abstract readSystematic Review
In one paragraph

Synthesis in Archives of disease in childhood. Fetal and neonatal edition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

3 authors.

Kristy P RobledoNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia kristy.robledo@sydney.edu.au.ORCID http://orcid.org/0000-0003-0213-7652
Sol LibesmanNHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
Lisa Nicole YellandWomen and Kids Theme, South Australian Health and Medical Research Institute Limited, Adelaide, South Australia, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo conduct a methodological systematic review of multicentre trials of premature infants to (1) determine if and how multiple births have been considered in the design, analysis and reporting of recent trials and (2) assess whether there has been an improvement since the last review was conducted 10 years ago.

designA systematic search was conducted in PubMed on 28 June 2023 for articles published between June 2018 and June 2023. Articles were eligible for inclusion if they were a multicentre randomised trial of infants born preterm and reported the results of a primary outcome that was measured on an infant or could be attributed to an infant.

resultsWe reviewed 62/74 trials (80%), after determining it was unclear if multiple births were present in the other 20%. 87% of trials (54/62) did not account for multiple births in their sample size calculations and 48% (30/62) did not account for clustering due to multiple births in their analyses. Problems were not limited to lower-ranked journals. No trials reported the intraclass correlation coefficient for any outcomes, indicating the degree of clustering present.

conclusionsPersistent problems remain with the design and analysis of multicentre trials of premature infants due to ignoring the complexity that comes with the inclusion of multiple births, despite methods available to address this. Trialists should consider the impact of multiple births in their trial design and analysis. Readers of neonatal trials should be aware of these issues, particularly those who peer review papers.

Indexed as

Infant, PrematureMultiple Birth OffspringRandomized Controlled Trials as TopicResearch DesignHumansInfant, NewbornMulticenter Studies as TopicPregnancyNeonatologyPaediatricsStatisticsTwins

Identifiers

PMID39653500
PMCPMC12229078

What Socratic holds

Textmetadata
LicenceCC BY
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.