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

NCT04738058 | Unknown Phase 1 DMC

• 1 other identifier: MD.20.08.344
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Feeding Intolerance in Preterm; Intestinal Permeability in Preterm

Keywords

Bovine lactoferrin; feeding intolerance; intestinal permeability; preterm

Outcome Measures

Primary Outcomes (2)

• Duration required by the infant to achieve full enteral feeding

  Full enteral feed reached when infant tolerated 150ml/kg/day

  4 weeks or till discharge from NICU, whichever came first

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

  serum zonulin is an indicator for intestinal permeability

  4 weeks or till discharge from NICU, whichever came first

Secondary Outcomes (9)

• Number of episodes of gastric residual more than 50% of the previous feed

  4 weeks or till discharge from NICU, whichever came first

• Weight gain

  4 weeks or till discharge from NICU, whichever came first

• Late onset sepsis

  4 weeks or till discharge from NICU, whichever came first

• Total numbers of days of antimicrobial administration

  4 weeks or till discharge from NICU, whichever came first

• Duration of parenteral nutrition

  4 weeks or till discharge from NICU, whichever came first

Study Arms (2)

Preterm infants diagnosed as feeding intolerance will receive bovine lactoferrin

EXPERIMENTAL

they will receive bovine lactoferrin 100mg/day with feeding for 4 weeks or until discharge for preterm that was diagnosed as feeding intolerance

Drug: Bovine Lactoferrin Supplement

Preterm infants diagnosed with feeding intolerance will receive placebo

PLACEBO COMPARATOR

they will receive the placebo with feeding for 4 weeks or until discharge for preterm that was diagnosed as feeding intolerance

Drug: placebo

Interventions

Bovine Lactoferrin Supplement DRUG

Bovine lactoferrin or placebo will be given to both arms with each feed for 30 days or till discharge from NICU the Lactoferrin dose 100mg/day Then determin is effect by serum zonulin level

Also known as: Pravotin

Preterm infants diagnosed as feeding intolerance will receive bovine lactoferrin

placebo DRUG

placebo

Preterm infants diagnosed with feeding intolerance will receive placebo

Eligibility Criteria

• Age: 26 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Major congenital malformations Anatomical gastrointestinal anomalies Birth asphyxia Presence of NEC Neonate receiving Expressed breast milk Infant with history of cow's milk allergy

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• Ellakkany N, Abdel-Hady H, Eita AM, Mosaad YM, Megahed A. Influence of bovine lactoferrin on feeding intolerance and intestinal permeability in preterm infants: a randomized controlled trial. Eur J Pediatr. 2024 Nov 20;184(1):30. doi: 10.1007/s00431-024-05861-4.

  PMID: 39565449 DERIVED

Related Links

• Prophylactic lactoferrin for preventing late-onset sepsis and necrotizing enterocolitis in preterm infants

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed M Hassan, Professor

  Mansoura University Children Hospital

  STUDY DIRECTOR

• Hesham S Abd El Hady

  Mansoura University Children Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Closed sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nermeen mohamed reda ellakany

Model Details: Group A: preterm infants with feeding intolerance receive lactoferrin Group B: preterm infants with feeding intolerance receive placebo

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 4, 2021
• Study Start: December 15, 2020
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: February 4, 2021

Record last verified: 2021-01

Locations

EG (1)