UnknownPhase 1

Influence of Bovine Lactoferrin on Feeding Intolerance and Intestinal Permeability in Preterm Neonates

Egypt60 participantsStarted 2020-12-15

Plain-language summary

Preterm infants are at increased risk of developing feeding intolerance due to functional immaturity of their gastrointestinal tract and may lead to discontinuation of enterak feeding. Lactoferrin promotes the growth of probiotic bacteria, stimulates differntiation and proliferation of enterocytes and expression of intestinal digestive enzymes , lead to improvement of feeding intolerance. So we hypothesized that supplementation of bovine lactoferrin would be benificial on feeding intolerance and decrease intestinal permeability in preterm infants with feeding intolerance.

Who can participate

Age range

26 Weeks – 34 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * preterm infants delivered at gestational age 26 to 34 weeks admitted to NICU OF mansoura university children hospital Diagnosed as feeding intolerance defined as gastric volume residual of more than 50% of the previous feeding volume, gastric regurgitation, abdominal distention and or emesis Receive premature cow's protein based formula enteral feeding Exclusion Criteria: Major congenital malformations Anatomical gastrointestinal anomalies Birth asphyxia Presence of NEC Neonate receiving Expressed breast milk Infant with history of cow's milk allergy \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration required by the infant to achieve full enteral feeding

Timeframe: 4 weeks or till discharge from NICU, whichever came first

Serum zonulin concentrations at day 7 and 4 weeks after enrollment or discharge

Timeframe: 4 weeks or till discharge from NICU, whichever came first

Trial details

NCT IDNCT04738058

SponsorMansoura University Children Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

View on ClinicalTrials.gov More Feeding Intolerance in Preterm trials