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NCT Number: NCT07088302

Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

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.

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Key information

Conditions

Premature Feeding Disorders Feeding and Eating Disorders Female Urogenital Diseases and Pregnancy Complications Lactase Deficiency, Congenital Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases

Age range

3 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

lactase administration

Drug

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

Placebo

Other

10 ml milk without lactase

Primary outcomes

  1. Feeding intolerance:

    Time frame: first two weeks of life

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa M Farag, PhD

CONTACT

[email protected]

01288681788

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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