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

Aims

Complications of preterm birth are the most common direct cause of mortality in children under 5 years, causing >1 million deaths per year, predominantly in low resource settings. Kangaroo mother care (KMC) is a recommended package of care for stable newborns but an evidence gap exists for early use prior to stability, with potential for high impact from improved family centred care. This trial aimed to investigate clinical effects of early kangaroo mother care (eKMC) for mild-moderately unstable neonates <2000g in a low-resource setting. Objectives included: 1) Effect on survival; 2) Effect on other clinically important outcomes such as weight gain and infection; 3) Safety of KMC prior to stability and exploration of mechanisms of effect.

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 - 24h with exclusion if stable or severely unstable as per protocol criteria. Neonates were randomly assigned to receive either standard care (control), including KMC once stable at >24h after admission, versus continuous KMC initiated <24h 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 cardiorespiratory stability at 24h; exclusive breastfeeding at discharge; suspected infection between 3-28d; weight gain at 28d and admission duration. The trial was prospectively registered at www.clinicaltrials.gov (NCT03555981).

Results

Recruitment occurred from 23^rd May 2018 to 19^th 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 (figure 1). 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) (table 1). 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, most frequently severe instability, apnoea and severe jaundice. Intervention fidelity was low with median daily skin-to-skin duration 6.9h/day, versus the intended target of 18h/day.

Conclusion

We did not find evidence that early KMC prior to stability is associated with improved survival or clinical outcomes in a resource limited setting. However, interpretation of this is limited due to a small sample size resulting from halving of pre-trial neonatal mortality rates, highlighting the substantial survival gains possible from implementation of existing recommended small and sick newborn care. Implementation and safety insights from this trial have value for further development of the intervention and wider roll-out of KMC. Further mortality and safety data are needed from varying low and middle-income neonatal unit contexts before global policy changes can be recommended.