1. In this study, enteric administration of recombinant human insulin was safe in preterm infants.
2. Insulin supplementation of human milk or formula given to preterm infants reduced time to achieve full enteric feeding in these patients.
Evidence Rating Level: 1 (Excellent)
Feeding intolerance due to immature gastrointestinal track development is prevalent among premature infants and causes significant morbidity and mortality. Preterm infants fed with mother’s own milk, which contains insulin, have been shown to promote intestinal maturation and decrease symptoms of feeding intolerance. However, whether addition of recombinant human insulin (rh insulin) to enteral feeds for preterm infants is safe and effective in reducing feeding intolerance has not been rigorously tested.
This multi-country randomized-control trial tested the safety and efficacy of supplementing human milk or formula with rh insulin for preterm infants. 303 infants born between 26 and 32 weeks of gestational age were randomized to receive either placebo, low, or high dose rh insulin in a 1:1:1 ratio. Infants with congenital malformations, infection, and hyperinsulinemia were excluded. The primary outcome measured was time to achieve full enteral feeding (FEF) defined as enteral intake of at least 150mL/kg per day for 3 consecutive days. The study was stopped 28 days after start of intervention or whenever the primary end point was reached.
Infants receiving low (10 days) and high (10 days) dose rh insulin achieved FEF in a shorter amount of time compared to infants receiving placebo (14 days). There was no significant difference in rates of severe adverse events in interventional and placebo groups. Lastly, no infants in the interventional group developed insulin antibodies. Overall, this study provided robust results that support the use of rh insulin as a supplement in human milk or formula feeding of preterm infants. However, one limitation of this study was its small size and use of only two doses of insulin. Therefore, further prospective studies testing different concentrations of insulin and more long-term indicators of nutritional state and development would be necessary to help determine how to use rh insulin supplementation in the most clinically effective and relevant manner.
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