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Recruiting Not applicable

Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

NCT07088302 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-08-30
Last updated
2026-01-16

Condition(s) studied

PrematureFeeding DisordersLactase Deficiency, Congenital

Investigational drug(s) / intervention(s)

lactase administrationplacebo

lactase administration: 1 drop for each 10 ml of formula milk for 14 days

placebo: 10 ml milk without lactase

Study summary

This study aims to study the effect of lactase enzyme in preventing feeding intolerance in preterm neonates in neonatal intensive care unit at Alexandria University Children's Hospital.

Eligibility

Sex
ALL
Min age
3 Days
Max age
1 Month
Healthy volunteers
No
Inclusion criteria will be as follows: * Preterm neonates ≤ 32 weeks gestational age. * Start feeding in the first 72 hours of life. 8. Exclusion criteria Patients with any of the following will be excluded: 1. Parental consent lacking/refusal. 2. Obvious major congenital abnormalities. 3. Infants more than 72 hours of age at the time of randomization. 4. Delayed introduction of feeding (beyond three days of life). 5. Known galactosemia. 6. Severe IUGR. -

Primary outcome measure(s)

  • Feeding intolerance: — first two weeks of life
    vomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds

Trial sites (1)

FacilityCityRegionStatus
Marwa Mohamed Farag Alexandria Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07088302 on ClinicalTrials.gov ↗ ← All trials in Egypt