Neonatal Clinical Trials
Neonatal Clinical Trials 1
SHABINA ARIFF, MD, FCPS (she/her/hers)
Associate Professor
AKU
karachi, Sindh, Pakistan
To assess the effect of community KMC (cKMC) on neonatal mortality, exclusive breastfeeding, weight gain and incidence of possible serious bacterial infection (PSBI).
Design/Methods:
A cluster-randomized control trial was conducted in rural Pakistan. 24 clusters were randomized to intervention and control arms. A pregnancy surveillance system instituted in study areas identified pregnant women. Stable neonates weighing ≥1200 to < 2500g were recruited within 72 hours of birth. Neonates in intervention clusters received cKMC while those in control received essential newborn care. The intervention package comprised KMC calendar in local language and KMC kit with diapers, caps, socks, towels, soap, and sanitary pads. Community mobilization included one-to-one and group sessions and peer to peer learning through KMC champions. An independent team collected data on vital status and outcomes.
Results: Between April 2019 and October 2021, 4977 neonates were enrolled, 2468 from intervention and 2510 from control clusters. 99.8% parents in intervention clusters performed KMC for 26.9±3.8 days with a mean duration of 7.8±3.7 hours/day. Risk of neonatal mortality was lower in intervention clusters (HR:0.66, 95% CI:0.44-0.99, p=0.045). Proportion of exclusive breastfeeding at 6 months was 36.5% in intervention and 6.8% in control clusters, p< 0.001. From enrolment to 59 days, 15.1% and 39.9% infants in the intervention and control arm, respectively had symptoms of PSBI, p=0.002. Risk of stunting at 6 months (RR:0.76, 95% CI:0.62-0.93 p=0.007) was lower among infants in the intervention arm. However, risk of wasting was similar in both groups (RR:0.73, 95% CI:0.51-1.06 p=0.095)
Conclusion(s):
Our findings suggest that KMC is feasible in community context and can reduce neonatal mortality, increase exclusive breastfeeding rates, and decrease risk of PSBI and stunting. We recommend that cKMC be scaled-up to improve neonatal outcomes in Pakistan and other developing countries.