Background: Understanding the effect of early kangaroo mother care on survival of mild-moderately unstable neonates <2000 g is a high-priority evidence gap for small and sick newborn care.
Methods: This non-blinded pragmatic randomised clinical trial was conducted at the only teaching hospital in The Gambia. Eligibility criteria included weight <2000g and age 1-24 h with exclusion if stable or severely unstable. Neonates were randomly assigned to receive either standard care, including KMC once stable at >24 h after admission (control) versus KMC initiated <24 h after admission (intervention). Randomisation was stratified by weight with twins in the same arm. The primary outcome was all-cause mortality at 28 postnatal days, assessed by intention to treat analysis. Secondary outcomes included: time to death; hypothermia and stability at 24 h; breastfeeding at discharge; infections; weight gain at 28d and admission duration. The trial was prospectively registered at 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.
Keywords: CFR, (Case-fatality rate); CI, (confidence interval); CLSI, (Clinical & Laboratory Standards Institute); CONSORT, (Consolidated Standards of Reporting Trials); CSF, (Cerebral-Spinal Fluid); DSMB, (Data Safety Monitoring Board); EFSTH, (Edward Francis Small Teaching Hospital); GEE, (Generalized Estimating Equation); HR, (Hazard Ratio); ICH-GCP, (International Conference on Harmonisation – Good Clinical Practice); IQR, (Inter Quartile Range); ISO, (International organisation for standardisation); IV, (intravenous); KMC, (Kangaroo mother care); Kangaroo Mother Care; Kangaroo method; LMIC, (Low and middle-income countries); LSHTM, (London School of Hygiene & Tropical Medicine); MDR, (Multi-drug resistant); MRCG, (Medical Research Council Unit The Gambia at London School of Hygiene & Tropical Medicine); Mortality; NA, (not applicable); NNU, (Neonatal Unit); Neonate; Newborn; Premature; RCT, (Randomised controlled trial); RD, (Risk difference); RDS, (Respiratory Distress Syndrome); RR, (Risk Ratio); SAE, (Serious Adverse Event); SD, (Standard Deviation); SDG, (Sustainable Development Goal); SSA, (Sub-Saharan Africa); Skin-to-skin contact; Survival; WHO, (World Health Organisation); aPSBI, (adapted Possible Severe Bacterial Infection); aSCRIP, (adapted Stability of Cardio-respiratory in Preterm infants); bCPAP, (bubble Continuous Positive Airway Pressure); eKMC trial, (early Kangaroo Mother Care before Stabilisation trial).
© 2021 The Authors.