NCT07088302

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

July 19, 2025

Last Update Submit

January 15, 2026

Conditions

PrematureFeeding DisordersLactase Deficiency, Congenital

Outcome Measures

Primary Outcomes (1)

  • Feeding intolerance:

    vomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds

    first two weeks of life

Study Arms (2)

Lactase enzyme group

ACTIVE COMPARATOR
Drug: lactase administration

Control group

PLACEBO COMPARATOR
Other: placebo

Interventions

lactase administrationDRUG

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

Lactase enzyme group
placeboOTHER

10 ml milk without lactase

Control group

Eligibility Criteria

Age3 Days - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm neonates ≤ 32 weeks gestational age.

You may not qualify if:

  • Patients with any of the following will be excluded:
  • Parental consent lacking/refusal.
  • Obvious major congenital abnormalities.
  • Infants more than 72 hours of age at the time of randomization.
  • Delayed introduction of feeding (beyond three days of life).
  • Known galactosemia.
  • Severe IUGR. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Mohamed Farag

Alexandria, 0325, Egypt

RECRUITING

MeSH Terms

Conditions

Premature BirthFeeding and Eating DisordersLactase Deficiency, Congenital

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Marwa M Farag, PhD

CONTACT

01288681788d.marwa.farag@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Pediatrics

Study Record Dates

First Submitted

July 19, 2025

First Posted

July 28, 2025

Study Start

August 30, 2025

Primary Completion

February 28, 2026

Study Completion

March 28, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

EG(1)