Efficacy and Safety of Enteral Recombinant Human Insulin in Preterm Infants: A Randomized Clinical Trial.

ABSTRACT:

Importance

Feeding intolerance is a common condition among preterm infants owing to immaturity of the gastrointestinal tract. Enteral insulin appears to promote intestinal maturation. The insulin concentration in human milk declines rapidly post partum and insulin is absent in formula; therefore, recombinant human (rh) insulin for enteral administration as a supplement to human milk and formula may reduce feeding intolerance in preterm infants.

Objective

To assess the efficacy and safety of 2 different dosages of rh insulin as a supplement to both human milk and preterm formula.

Design, setting, and participants

The FIT-04 multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 46 neonatal intensive care units throughout Europe, Israel

SUBMITTER: Mank E 

PROVIDER: S-EPMC8886453 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature