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COMPLETED
NCT07784062
NA

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Days - 28 Days

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-11-20

Completion Date

2026-06-10

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

Lactase enzyme

Lactase enzyme treated feeds

OTHER

Distilled water

Distilled water administered as placebo to the control group during enteral feeding.

Locations (1)

NICU of Ain shams university hospitals

Cairo, Cairo Governorate, Egypt