Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

NCT ID: NCT07088302

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-30

Study Completion Date

2026-03-28

Brief Summary

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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.

Detailed Description

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Conditions

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Premature Feeding Disorders Lactase Deficiency, Congenital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactase enzyme group

Group Type ACTIVE_COMPARATOR

lactase administration

Intervention Type DRUG

1 drop for each 10 ml of formula milk for 14 days

Control group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

10 ml milk without lactase

Interventions

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lactase administration

1 drop for each 10 ml of formula milk for 14 days

Intervention Type DRUG

placebo

10 ml milk without lactase

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Preterm neonates ≤ 32 weeks gestational age.

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. -
Minimum Eligible Age

3 Days

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Farag

Assistant professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marwa Mohamed Farag

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwa M Farag, PhD

Role: CONTACT

01288681788

Facility Contacts

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Marwa M Farag

Role: primary

01288681788

Other Identifiers

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0108387

Identifier Type: -

Identifier Source: org_study_id

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