Effect of Enteral Bovine Lactoferrin in Preterm Infants

NCT06015828 | Completed

• 1 other identifier: AinShamsUlactoferrin
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• neurobehavioral outcome

  The present study is designed to evaluate the effect of oral administration of bovine lactoferrin on the neurobehavioral performance of preterm neonates at 36 weeks corrected age using the Neonatal Intensive Care Unit Neurobehavioral Scale (NNNS). ( minimum 0 , maximum 3 in each category)

  at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.

• Morbidity

  Define any morbidities from oral lactoferrn administration

  At 36 weeks corrected gestational age

• Mortality

  To assess number of deaths in the study group

  36 corrected gestational age

Secondary Outcomes (1)

• effect on morbidity and mortality

  at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.

Study Arms (2)

lactoferrin group

EXPERIMENTAL

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. (Asztalos.,et al 2020)

Dietary Supplement: bovine lactoferrin

control group

NO INTERVENTION

Neonates will receive their routine feds and will not receive lactoferrin.

Interventions

bovine lactoferrin DIETARY_SUPPLEMENT

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.

lactoferrin group

Eligibility Criteria

• Age: 1 Hour - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Stable preterm neonates
• gestational age less than 35 weeks
• younger than 72 hours at randomization
• have initiated enteral feds.

You may not qualify if:

• \. Neonates with underlying gastrointestinal problems that prevent oral intake. 2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities,
• structural brain anomalies,
• severe congenital abnormalities). 3. Neonates with a history of perinatal hypoxia. 4. Neonates with a family background of cow milk allergy. 5. Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 1825, Egypt

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• maha mohamed, PHD

  Ain Shams University

  STUDY DIRECTOR

• dina shinkar, PHD

  Ain Shams University

  STUDY DIRECTOR

• mariam ibrahim, PHD

  Ain Shams University

  STUDY DIRECTOR

• mahmoud kofory, MB.,B.CH

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded randomized controlled trial Neonates will be randomized using closed envelopes into two groups
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatrics, Ian shams university

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 29, 2023
• Study Start: September 20, 2021
• Primary Completion: September 20, 2022
• Study Completion: April 20, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

EG (1)