Menu
Recruiting NCT07088302

Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

No phase Interventional Premature Feeding Disorders Lactase Deficiency, Congenital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lactase administration, placebo.
Who it may be relevant to
Registry conditions: Premature, Feeding Disorders, Lactase Deficiency, Congenital. Basic parameters: 3 Days — 1 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug lactase administration
    1 drop for each 10 ml of formula milk for 14 days
  • Other placebo
    10 ml milk without lactase

Primary outcome measures

  • Feeding intolerance: [Time frame: first two weeks of life]

Eligibility 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:

  • 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. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Marwa Mohamed Farag — Alexandria

Identifiers

NCT: NCT07088302 · 0108387

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗