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Completed
NCT07784062
The Effect of Lactase-Treated Feeds on Feeding Intolerance in Preterm Infants
Conditions: Feeding Intolerance in Preterm Infants
Sex: All
Ages: 0 Days – 28 Days
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Ain Shams University
Location: NICU of Ain shams university hospitals Cairo Cairo Governorate
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.
Eligibility Criteria
Inclusion Criteria
* Gestational age \3 mL/kg or the specified vomiting/stool/abdominal-distension.
Exclusion Criteria:
* Severe congenital malformations, including GI or cardiac defects.
* NEC according to Bell's staging criteria.
* Congenital diarrhea.
* Hemodynamic instability requiring inotropes.
* Amino-acid-based or lactose-free formula.
* Guardian declines consent.
Source: ClinicalTrials.gov (NCT07784062). StuddyBuddy aggregates publicly available trial information.