Actively Recruiting
Effect of Lactase Enzyme Supplements on Protection Against Feeding Intolerance in Preterm Neonates
Led by Alexandria University · Updated on 2026-01-16
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of lactase enzyme supplements in preventing feeding intolerance among preterm newborns in a neonatal intensive care unit. The study focuses on preterm neonates born at or before 32 weeks gestational age who start feeding within the first 72 hours of life. This research is important to understand how lactase enzyme may support feeding in these vulnerable infants. Participants will be randomly assigned to receive either lactase enzyme drops added to their formula milk or a placebo with no lactase. The lactase group will receive one drop per 10 ml of formula for 14 days. The control group will receive 10 ml of milk without lactase. The study includes a 14-day treatment period starting shortly after feeding begins. During the study, researchers will monitor feeding intolerance during the first two weeks of life. Assessments will include careful observation of feeding tolerance, clinical status, and any complications. The study will follow infants closely with routine evaluations to measure the main outcome related to feeding tolerance. The total duration of participation aligns with the initial two weeks of feeding after birth.
CONDITIONS
Brief Title
Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm neonates born at or before 32 weeks gestational age
- Started feeding within the first 72 hours of life
- Age between 3 days and 1 month at enrollment
You will not qualify if you...
- Lack of parental consent or refusal to participate
- Major congenital abnormalities present
- Infant older than 72 hours at the time of randomization
- Feeding started after three days of life
- Known diagnosis of galactosemia
- Severe intrauterine growth restriction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive lactase enzyme supplements or placebo administered with formula milk.
Daily administration for 14 days
Trial Site Locations
Total: 1 location
1
Marwa Mohamed Farag
Alexandria, Egypt, 0325
Actively Recruiting
Research Team
M
Marwa M Farag, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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