The Effect of Lactase-Treated Feeds on Feeding Intolerance in Preterm Infants

Overview

The purpose of this study is to evaluate whether adding lactase enzyme to milk feeds can improve feeding tolerance in preterm neonates. Preterm infants may have immature gastrointestinal function and reduced intestinal lactase activity, which may contribute to difficulty digesting lactose and symptoms of feeding intolerance. In this study, eligible preterm neonates will be randomly assigned to receive either lactase-treated milk feeds or placebo-treated milk feeds. Feeding tolerance will be assessed using clinical and nutritional parameters during the study period. The study will compare the two groups to determine whether lactase supplementation improves feeding tolerance and supports better progression of enteral feeding in preterm neonates. The hypothesis is that lactase-treated feeds will reduce feeding intolerance and facilitate achievement of adequate enteral feeding compared with placebo.

This is a randomized, controlled, parallel-group interventional study designed to evaluate the effect of lactase-treated feeds on feeding intolerance in preterm neonates. Preterm neonates are at increased risk of feeding intolerance because of gastrointestinal immaturity, delayed gastric emptying, immature intestinal motility, and incomplete development of digestive enzyme activity. Lactase activity may be relatively low in preterm infants, potentially resulting in incomplete lactose digestion and contributing to gastrointestinal symptoms associated with feeding intolerance. Eligible preterm neonates will be enrolled according to predefined inclusion and exclusion criteria. Participants will be randomly allocated into two groups. The intervention group will receive milk feeds treated with lactase enzyme, while the control group will receive milk feeds treated with placebo. The placebo will consist of distilled water administered in an equivalent manner to the lactase preparation. The study will evaluate feeding tolerance throughout the study period. Clinical parameters related to feeding tolerance will be recorded, including the occurrence and severity of feeding intolerance manifestations and the progression of enteral feeding. Nutritional and growth-related parameters will also be assessed according to the study protocol. The primary objective is to determine whether lactase-treated feeds improve feeding tolerance in preterm neonates compared with placebo-treated feeds. Secondary objectives include evaluating the effect of lactase supplementation on the progression of enteral feeding and selected nutritional and growth outcomes. The study is expected to provide evidence regarding whether exogenous lactase supplementation may be beneficial in preterm neonates experiencing feeding intolerance