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Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

Effect OF Lactase Enzyme Supplements ON Protection Against Feeding Intolerance IN Preterm Neonates

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07088302
Enrollment
120
Registered
2025-07-28
Start date
2025-08-30
Completion date
2026-03-28
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Disorders, Lactase Deficiency, Congenital, Premature

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.

Interventions

DRUGlactase administration

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

OTHERplacebo

10 ml milk without lactase

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Days to 1 Months
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. -

Design outcomes

Primary

MeasureTime frameDescription
Feeding intolerance:first two weeks of lifevomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds

Countries

Egypt

Contacts

CONTACTMarwa M Farag, PhD
d.marwa.farag@gmail.com01288681788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026