Lactase enzyme to reduce feeding problems in very preterm babies

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

The team will try giving lactase enzyme to babies born before 32 weeks who start feeds in the first 72 hours to see if it prevents feeding intolerance in the NICU.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 3 Days to 1 Month
• Sex: All
• Sponsor: Alexandria University (Academic / other)
• Locations: 1 site (Alexandria)
• Trial ID: NCT07088302 on ClinicalTrials.gov

What this trial studies

Preterm infants born at or before 32 weeks who begin enteral feeding within 72 hours will be enrolled at Alexandria University Children's Hospital and given either a lactase enzyme preparation or a matching placebo. Clinical staff will administer the assigned treatment around feeds and monitor infants for signs of feeding intolerance and feeding progression while in the neonatal intensive care unit. Key eligibility excludes infants with major congenital abnormalities, known galactosemia, severe intrauterine growth restriction, delayed feeding beyond three days, or lack of parental consent. The intervention aims to determine whether supplemental lactase can reduce feeding intolerance in this high-risk neonatal population.

Who should consider this trial

Good fit: Ideal candidates are infants born at or before 32 weeks gestation who start enteral feeding within the first 72 hours of life and whose parents provide consent, with no major congenital anomalies or known galactosemia.

Not a fit: Infants older than 72 hours at randomization, with major congenital anomalies, severe IUGR, delayed feeding beyond three days, or known galactosemia would be excluded and likely would not benefit from this intervention.

Why it matters

Potential benefit: If successful, this could reduce feeding intolerance and help very preterm infants reach full enteral feeds sooner, potentially shortening NICU stays.

How similar studies have performed: Some small studies in older infants and term populations have shown symptomatic improvement with lactase supplementation, but evidence specifically in very preterm neonates is limited and this approach is not yet well established for that group.

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:

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. -

Where this trial is running

Alexandria

• Marwa Mohamed Farag — Alexandria, Egypt (Recruiting)

Study contacts

• Study coordinator: Marwa M Farag, PhD

Conditions Premature; Feeding Disorders; Lactase Deficiency, Congenital