drugset / Trial / NCT07784062

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

NCT07784062 ↗

Completed 70 enrolled Ain Shams University
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2025-11-20
Primary completion
2025-11-30
Completion
2026-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject lactase Protein / enzyme biologic — Other

Indications

No indication recorded.