Objective: Clear outcome reporting in clinical trials facilitates accurate interpretation and
application of findings and improves evidence-informed decision-making. Standardized core
outcomes for reporting neonatal trials have been developed, but little is known about how
primary outcomes are reported in neonatal trials. Our aim was to identify strengths and
weaknesses of primary outcome reporting in recent neonatal trials.
Methods: Neonatal trials including ≥100 participants/arm published between 2015-2020 with at
least one primary outcome from a neonatal core outcome set were eligible. Raters recruited from
Cochrane Neonatal were trained to evaluate the trials’ primary outcome reporting completeness
using relevant items from CONSORT 2010 and CONSORT-Outcomes 2022 pertaining to the
reporting of the definition, selection, measurement, analysis, and interpretation of primary trial
outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between
raters were analyzed.
Results: Outcome reporting evaluations were completed for 36 included neonatal trials by 39
raters. Levels of outcome reporting completeness were highly variable. All trials fully reported
the primary outcome measurement domain, statistical methods used to compare treatment
groups, and participant flow. Yet, only 28% of trials fully reported on minimal important
difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and
42% on handling of outcome multiplicity.
Conclusions: Primary outcome reporting in neonatal trials often lacks key information needed
for interpretability of results, knowledge synthesis, and evidence-informed decision-making in
neonatology. Use of existing outcome reporting guidelines by trialists, journals, and peer
reviewers will enhance transparent reporting of neonatal trials.