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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 range26 Weeks – 34 Weeks

SexALL

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 \-

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