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The Effect of Lactase-Treated Feeds on Feeding Intolerance in Preterm Infants
Sponsor: Ain Shams University
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
Conditions
Interventions
Lactase enzyme
Lactase enzyme treated feeds
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