Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

Alexandria University120 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Premature Feeding Disorders Lactase Deficiency, Congenital

Interventions

lactase administrationDRUG

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

placeboOTHER

10 ml milk without lactase

Eligibility

Sex: ALLMin age: 3 DaysMax age: 1 Month

Medical Language ↔ Plain English

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. -

Locations (1)

Marwa Mohamed Farag

Alexandria, Egypt

RECRUITING

Outcomes

Primary Outcomes

Feeding intolerance:

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

Time frame: first two weeks of life

Central Contacts

Marwa M Farag, PhD

CONTACT

01288681788 d.marwa.farag@gmail.com

Data from ClinicalTrials.gov

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