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Arch Dis Child Fetal Neonatal Ed. 2019 May 13. pii: fetalneonatal-2019-316823. doi: 10.1136/archdischild-2019-316823. [Epub ahead of print]

Inconsistent outcome reporting in large neonatal trials: a systematic review.

Author information

Section of Neonatal Medicine, Imperial College London, London, UK.
School of Medicine, Imperial College London, London, London, UK.
University of Bristol, Bristol, UK.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
UCL Institute of Education, University College London, London, UK.



Inconsistent outcome selection and reporting in clinical trials are important sources of research waste; it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection.


A literature search of CENTRAL, CINAHL, EMBASE and MEDLINE was conducted; randomised trials published between 1 July 2012 and 1 July 2017 and involving at least 100 infants in each arm were included. Outcomes and outcome measures were extracted and categorised by physiological system; reported former patient and parent involvement in outcome selection was extracted.


Seventy-six trials involving 43 126 infants were identified; 216 different outcomes with 889 different outcome measures were reported. Outcome reporting covered all physiological systems but was variable between individual trials: only 67/76 (88%) of trials reported survival and 639 outcome measures were only reported in a single trial. Thirty-three composite outcomes were used in 41 trials. No trials reported former patient or parent involvement in outcome selection.


Inconsistent outcome reporting and a lack of parent and former patient involvement in outcome selection in neonatal clinical trials limits the ability of such trials to answer clinically meaningful questions. Developing and implementing a core outcome set for future neonatal trials, with input from all stakeholders, should address these issues.


neonatology; outcomes research; patient perspective

Conflict of interest statement

Competing interests: CG is part of an international team developing reporting guidance (a CONSORT extension) for clinical trials using cohorts and routinely collected health data. He has received support from Chiesi Pharmaceuticals to attend an educational conference; in the past 5 years, he had been the investigator on received research grants from Medical Research Council, National Institute of Health Research, Canadian Institute of Health Research, Department of Health in England, Mason Medical Research Foundation, and Westminster Medical School Research Trust and Chiesi Pharmaceuticals; JW has received support from Chiesi Pharmaceuticals to attend an educational conference and has received a research grant from Mason Medical Research Foundation.

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