Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

Alexandria University

Status: Enrolling

Conditions: Premature; Lactase Deficiency, Congenital; Feeding Disorders

Treatments: Other: placebo; Drug: lactase administration

Study type: Interventional

Funder types: Other

Identifiers

NCT07088302

0108387

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 3 days to 1 month old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Lactase enzyme group

Active Comparator group

Treatment:

Drug: lactase administration

Control group

Placebo Comparator group

Treatment:

Other: placebo