Impact of early kangaroo mother care versus standard care on survival of mild-moderately unstable neonates <2000 grams: A randomised controlled trial

Abstract Background Understanding the effect of early kangaroo mother care on survival of mild-moderately unstable neonates Methods This non-blinded pragmatic randomised clinical trial was conducted at the only teaching hospital in The Gambia. Eligibility criteria included weight 24 h after admission (control) versus KMC initiated www.clinicaltrials.gov (NCT03555981). Findings Recruitment occurred from 23rd May 2018 to 19th March 2020. Among 1,107 neonates screened for participation 279 were randomly assigned, 139 (42% male [n = 59]) to standard care and 138 (43% male [n = 59]) to the intervention with two participants lost to follow up and no withdrawals. The proportion dying within 28d was 24% (34/139, control) vs. 21% (29/138, intervention) (risk ratio 0·84, 95% CI 0·55 – 1·29, p = 0·423). There were no between-arm differences for secondary outcomes or serious adverse events (28/139 (20%) for control and 30/139 (22%) for intervention, none related). One-third of intervention neonates reverted to standard care for clinical reasons. Interpretation The trial had low power due to halving of baseline neonatal mortality, highlighting the importance of implementing existing small and sick newborn care interventions. Further mortality effect and safety data are needed from varying low and middle-income neonatal unit contexts before changing global guidelines. Funding This research was funded in whole by The Wellcome Trust [Ref. 200116/Z/15/Z] as a Research Training Fellowship to HB. For the purpose of open access, the author has applied a CC BY public copyright license to any Author Accepted Manuscript version arising from this submission. We have not been paid to write this article by a pharmaceutical company or other agency. The sponsor was London School of Hygiene & Tropical Medicine (LSHTM), London, UK. Reference: QA1078.