Level 2: Mid-level evidence
Early continuous insulin infusion in very-low-birth-weight (VLBW) infants aged 1-7 days is associated with significantly increased mortality at 28 days and increased hypoglycemia, based on an open-label randomized trial involving 389 participants (N Engl J Med. 2008;359:1873-1884). In infants receiving insulin, mortality at 28 days was 11.9% (vs. 5.7% with standard care); increased hypoglycemia occurred in 29% of babies receiving insulin compared with 17% who were not.
In a prespecified subgroup analysis, the difference in hypoglycemia was significant only in infants with birth weight >1 kg. Hyperglycemia was significantly decreased in babies receiving early insulin therapy (21% vs. 33%). There were no significant differences in development of sepsis, necrotizing enterocolitis, retinopathy of prematurity, intracranial disease, or chronic lung disease or in mortality at expected date of delivery. The trial was terminated early due to concerns of potential harm and failure to demonstrate benefit from insulin treatment.