Effect of Enteral Insulin on Time to Reach Full Enteral Feeding in Preterm Infants ≤ 32 weeks and ≤ 1250 grams: A Randomised Controlled Trial

This is a randomised controlled trial to study the effect of enteral insulin on time to reach full enteral feeding in preterm infants ≤ 32 weeks and ≤ 1250 grams. Preterm infants have an immature gut, reduced digestive capacity and poor intestinal motility. This leads to an increase in the time to reach full enteral feeding, thereby increasing the duration of parenteral nutrition, length of hospital stay and risk of sepsis. insulin present in breast milk is known to have a beneficial influence on maturation of gut. Insulin when supplemented orally, has a local effect on gut mucosa and helps in enterocyte proliferation, increased enzyme activity and improved absoprtive capacity of gut. Two randomised controlled trials on enteral insulin have reported benefits in terms of decreased time to reach full enteral feeding, improved feeding tolerance and decrease in duration of parenteral nutrition. These benefits could further translate in reduction in rates of sepsis and other PN associated complications. this can have important implications in the developing countries where this strategy has not been studied. we plan to conduct a randomised controlled trial to study the effect of enteral insulin on time to reach full enteral feeding in preterm infants ≤ 32 weeks gestation and ≤ 1250 gram birth weight. eligible infants will be randomly allocated into two groups, Group A (enteral insulin group) and group B (placebo group). we hypothesize that enteral insulin therapy compared to placebo will decrease time to reach full enteral feeding in preterm infants ≤ 32 weeks gestation and ≤ 1250 gram birth weight by 2.5 days. Our primary objective is to compare the time to reach full enteral feeding defined as feeding volume of 180 ml/kg/day tolerated for 48 hours, in enteral versus placebo group. Our secondary objectives are time to reach enteral intake of 100ml/kg/day, duration of parenteral nutrition, episodes of feeding intolerance, time taken to regain birth weight, incidence of culture positive sepsis, incidence of necrotising enterocolitis, episodes of hypoglycemia, growth velocity at stoppage of intervention and at discharge for weight, length and head circumference, duration of hospital stay and all cause mortality