Funded by JGHT call 9 Trial development grant.
Deaths in the neonatal period (first 28 days) constitute 44% of all under 5 deaths. >80% of neonatal deaths occur in preterm and/or low birthweight (BW) infants and the great majority of these deaths occur in LMICs.
Probiotics are live organisms that have health benefits and are generally considered safe. In a review of 23 RCTs of preterm neonates (gestation<37 weeks; n=4783) in 10 LMICs, probiotics reduced all cause mortality (RR 0.73; 95% CI 0.59 to 0.90; P=0.003). Additional statistically significant benefits were reduced episodes of necrotising enterocolitis and late-onset sepsis. In a Cochrane review of all studies, time to reach full enteral feeds and hospital stay were also significantly decreased. Many NNUs in high and middle-income countries use probiotics routinely in preterm infants. Only two studies have been done in Africa (Egypt and South Africa).
We are undertaking a feasibility/pilot study of a probiotic preparation versus identical placebo in the neonatal unit at University Hospital Ibadan, Nigeria led by Dr. Kemi Tongo with collaborators in the University of Newcastle, UK. We hope that the results of this initial study will allow us to develop a cluster-randomised trial of this promising intervention.