Beardsall K et al. (2008) Early insulin therapy in very-low-birth-weight infants. N Engl J Med 359: 1873–1884

Hyperglycemia is common in babies who weigh <1.5 kg at birth and is associated with morbidity and mortality. Beardsall et al. investigated whether early insulin treatment improves glycemic control and survival in babies with very low birth weight.

This international, multicenter study enrolled 389 newborn babies younger than 24 h with a birth weight <1.5 kg. Babies randomly assigned to the treatment group received a fixed-dose, continuous infusion of insulin (0.05 (U/kg)/h) for 7 days. Babies randomly allocated to the control group received standard intensive care, and dextrose and insulin as needed.

The mean daily glucose level of the treatment group was significantly lower than that of the control group, and the mean daily energy intake was significantly higher in insulin-treated babies (P = 0.007 and P <0.001, respectively). The incidence of hypoglycemia among babies with a birth weight >1 kg, however, was higher in the insulin group than in the control group (P <0.001). No difference was observed between the groups in adjusted mortality before the expected date of delivery, but the rate of death before 28 days after birth was marginally higher in the insulin group (adjusted P = 0.02). The study was terminated early by the Trial Steering Committee on the grounds of futility for the primary outcome.

The authors conclude that elective use of early insulin therapy in newborn babies who weigh <1.5 kg does not improve survival, and is associated with an increased risk of hypoglycemia in those <1 kg in weight.