Extensively and partially hydrolysed preterm formulas in the prevention of allergic diseases in preterm infants: a randomized, double-blind trial

Aim: A randomized, double-blind study was conducted to evaluate whether use of protein hydrolysate-based preterm formulas in infants with an atopic predisposition helps prevent the development of allergic diseases. Methods: Preterm infants (n= 122) with at least one first-degree relative (parent or sibling) with allergic disease were randomly assigned to receive an extensively or partially hydrolysed preterm formula (intervention groups) or a standard preterm formula until 4 to 5 mo of age. Infants whose parents preferred that they be breastfed received their mothers' fortified breast milk. Results: Intention-to-treat analysis showed that the overall incidence of allergic diseases did not significantly differ between groups at both 4–5 and 12 mo of age. However, by 12 mo, use of the extensively hydrolysed versus the standard preterm formula had significantly reduced the risk of atopic dermatitis. At 4–5 and 12 mo, there was a significantly increased risk of non-acceptance of the extensively hydrolysed formula compared with the other formulas. Conclusions: This study failed to show that extensively or partially hydrolysed preterm formulas in comparison with a standard preterm formula reduced the overall incidence of allergic diseases in infants at high risk for atopic disease. However, use of the extensively hydrolysed compared with a standard preterm formula significantly reduced the incidence of atopic dermatitis observed at 12 mo. Infants who received extensively hydrolysed formulas were at increased risk for intervention discontinuation for any reason, particularly non-acceptance of the formula. Because of the small number of patients eligible for this analysis, these results should be interpreted with caution.