Lactase enzyme to reduce feeding problems in very preterm babies
Official title: Effect OF Lactase Enzyme Supplements ON Protection Against Feeding Intolerance IN Preterm Neonates
Run by Alexandria University · NCT07088302 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 3 Days to 1 Month |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Status | Recruiting |
| Started | August 30, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | March 28, 2026 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07088302 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Marwa Mohamed Farag
Alexandria, Egypt Recruiting
Study contacts
- Study coordinator: Marwa M Farag, PhD
- Email: d.marwa.farag@gmail.com
- Phone: 01288681788
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation
This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.
-
Breast milk and sugar solutions to ease heel-prick pain in premature babies
This study tests whether oral breastfeeding or sugary solutions help relieve pain in premature newborns during a heel-prick blood draw.
-
Gentle Touch and Sensory Changes to Ease Heel Pricks in Preterm Babies
This study tests whether gentle human touch or a quiet, reduced-stimulation environment can reduce pain and improve comfort during heel blood collection for premature infants.
-
Automated oxygen control for preterm babies on non-invasive support
This trial tests whether closed-loop automated oxygen control helps preterm babies on non-invasive ventilation reach target oxygen levels more often and spend less time on supplemental oxygen compared with manual control.
-
Lung ultrasound to predict breathing problems in late‑preterm babies
We will test whether early point‑of‑care lung ultrasound can predict which late‑preterm newborns will have breathing problems in the first 48 hours of life.
-
How the triglyceride–glucose (TyG) index relates to heart artery imaging in non‑diabetic adults with early coronary artery disease
This study will see if the triglyceride–glucose (TyG) index helps explain angiographic patterns in non‑diabetic adults who develop coronary artery disease at younger ages.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.