A feasibility and pilot trial of enteral probiotic administration in preterm infants admitted to a neonatal unit in Nigeria
Medical Research Council
University of Ibadan
Our proposal is based on a fixed effects meta-analysis of 23 RCTs of preterm infants in 10 LMICs (n=4,783; Deshpande 2017). Probiotics reduced all cause mortality (RR 0.73 [95% CI 0.59 to 0.90]; P=0.003), necrotising enterocolitis (RR 0.46 [0.34 to 0.61]; P<0.00001), late-onset sepsis (RR 0.80 [0.71 to 0.91]; P=0.0009) and time to full enteral feeds (-1.95 days; [-3.44 to -0.45]; P<0.00001). No adverse effects were ascribed to probiotics in the systematic review and there are only limited case reports of adverse effects in preterm/VLBW infants. Based on global clinical trial evidence, probiotic administration has becoming routine in many neonatal units in industrialised countries. The meta-analysis included only two studies in Africa (Egypt and South Africa) and neither may be representative of other neonatal units in the sub-continent. Probiotics effects likely differ according to host characteristics, exposure to environmental microbes and nosocomial pathogens, antibiotic use and feeding practices. There is an urgent need to test this intervention in low-resource settings with the highest rates of neonatal mortality. For selection of probiotic for neonates, network meta-analysis advises the inclusion of Lactobacilli and Bifidobacterium spp. to simulate the gut flora in the healthy, breast-fed infant and use of multistrain preparations that have greater beneficial effects including the prevention of NEC. For this initial study, we have selected a product that contains three probiotic strains (L acidophilus, B infantis, B bifidum) suspended in oil, manufactured in South Africa and with a long shelf life at room temperature. This probiotic is used extensively in highly vulnerable infants in neonatal practice in the UK and no significant safety concerns have arisen. This proposal aims to ultimately address the evidence gap regarding the potential health benefits of probiotics in preterm/VLBW infants in a low resource setting in sSA.
6.1 Pharmaceuticals / Research Grant