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No clinical benefit seen with early insulin therapy in infants with very low birth weight

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Early insulin therapy decreased hyperglycemia but increased hypoglycemia in infants with very low birth weight.

The multicenter randomized controlled trial was stopped early because of concerns that the primary outcome of mortality at the expected date of delivery was ineffective and because of concerns of potential harm.

The researchers randomly assigned 195 infants to continuous infusion of insulin 0.05 U per kg of body weight per hour with 20% dextrose support. They assigned another 194 infants to standard neonatal care on days one to seven. All infants were aged younger than 1 day and weighed <1,500 g.

Infants who received early insulin had lower mean glucose levels compared with those in the control group (6.2 mmol/L vs. 6.7 mmol/L; P=.007). Twenty-one percent of infants in the early-insulin group had hyperglycemia for >10% of the first week of life, compared with 33% in the control group (P=.008). Infants receiving early insulin also had more carbohydrate infused (P<.001) and lost less weight in the first week (P=.006). However, 29% of the infants in the early-insulin group had hypoglycemia compared with 17% in the control group (P=.005). According to the researchers, infants weighing >1 kg had a significant increase in hypoglycemia.

They also conducted an intent-to-treat analysis for mortality at the expected date of delivery and for morbidity and found no differences between the two groups. However, mortality at 28 days was higher in the early-insulin group than in the control group — 11.9% vs. 5.7% (P=.04). – by Tina DiMarcantonio

N Engl J Med. 2008;359:1873-1884.

The researchers of this study set out to determine if treating the hyperglycemia of VLBW infants with early insulin therapy is beneficial. Although the outcomes were unaffected, increased incidence of hypoglycemia was seen. Caution is required when treating with intensive insulin regimens.

– Derek LeRoith, MD, PhD

Endocrine Today Editorial Board member