Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-1
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm neonates ≤ 32 weeks gestational age.
Start feeding in the first 72 hours of life. 8.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
lactase administration
Drug1 drop for each 10 ml of formula milk for 14 days
placebo
Other intervention10 ml milk without lactase
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Lactase enzyme groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 lifeSponsors and contacts
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Source ClinicalTrials.gov