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Effect of Enteral Bovine Lactoferrin in Preterm Infants

NCT06015828 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-05-16

No results posted yet for this study

Summary

There is a preference for using enteral bovine lactoferrin for preterm infants. Lactoferrin is a sialic acid-rich, iron-binding milk glycoprotein, known to have multifunctional health benefits, including its ability to modulate immune function and facilitate iron absorption, as well as its antibacterial and anti inflammatory actions.

The study is an evaluation of the efficacy of enteral bovine lactoferrin on neurobehavioral performance in preterm infants.

Conditions

  • Neonatal Disease

Interventions

DIETARY_SUPPLEMENT

bovine lactoferrin

Neonates will receive a daily dose of 150 mg/kg body weight per day (up to a maximum of 300 mg/day) of bovine lactoferrin and will be prepared for administration by addition by syringe of sterile water (4 mL) orally or through gavage feeding, once the infant's enteral feed volume is more than 12 mL/kg per day until 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • maha mohamed, PHD · Ain Shams University

  • dina shinkar, PHD · Ain Shams University

  • mariam ibrahim, PHD · Ain Shams University

  • mahmoud kofory, MB.,B.CH · Al-Azhar University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2022-09-20
Completion
2023-04-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015828 on ClinicalTrials.gov