The Effect of Dual Strain Probiotic on the Growth and Feeding Intolerance in Premature Neonates of Kabul city: A Randomized Clinical Trial
Abstract Background: Prematurity is prevalent worldwide and accounts as the leading cause of neonatal death. Slow weight gain, feeding intolerance, prolong hospital stay, recurrent infection and high mortality are significant issues for preterm neonates. Dual strain probiotic can manage such complication of prematurity. Objective: To evaluate the effectiveness of dual strain probiotic on weight gaining and feeding intolerance of preterm neonates in Kabul city.Method: This randomized controlled trial conducted at Neonatal units of Malalai and Maiwand Hospitals in Kabul city. Finally, 84 preterm neonates assessed for the effect of dual strain probiotic. The clinical parameters were daily weight gain and the risk of feeding intolerance and neonatal mortality. Statically analysis was performed by SPSS 20. Results: Forty-two premature neonates in dual strain probiotic group and another forty-two preterm babies in control group were investigated. The preterm neonates in probiotic versus control group had mean age (7.2±6.3 vs 6.8±3.3 day; P=0.63), weight (1495.5±273 vs 1476.2±273 g; P=0.75) and gestational age (33.6±2.1 vs 32.9±2.4 week; p=0.14). Sex distribution in probiotic group was (boys 54.4%, girl 45.2%) and in control group was (boys 50%, girl 50%). Both groups were observed for mean days of (17.6±6.4 vs 18.8±6.3; P=0.45). The premature newborns in probiotic versus control group had mean daily weight gain (15.4±9.4 vs 10±7.9g; CI=1.75-9.31, P=0.005), risk of feeding intolerance (RR=0.65, CI=0.1-4.1, P=0.6) and risk of mortality during hospital stay (RR=0.65, CI=0.1-0.41, P=0.8).Conclusion: Preterm neonates in our country had slow growth than high-income countries. Dual strain probiotic significantly improved the daily weight gain of premature neonates. However, probiotic also decreased the risk of feeding intolerance and death during hospital stay but these findings were not statistically significant.Clinical trial registration number: This RCT was registered in the Australian New Zealand Clinical Trials Registry with the number of ACTRN12620000538943. Date of Registration is first May 2020. https://www.anzctr.org.au/ACTRN12620000538943.aspx