Effect of Enteral Bovine Lactoferrin in Preterm Infants

Not Applicable

Completed

• Conditions: Neonatal Disease
• Interventions: Dietary Supplement: bovine lactoferrin

• Registration Number: NCT06015828
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Over 15 million infants are born preterm \< 37 weeks gestation worldwide. Lactoferrin is about 80- kilo dalton kDa glycoprotein composed of 703 amino acid residues and is a member of the transferrin family, As a member of the transferrin family of iron-binding proteins, lactoferrin shares more than 60% homology at the amino acid level with transferrin and a 77% homology exists between human and bovine species.

Human lactoferrin is the most abundant glycoprotein. It contains 1- 4 Sialic acid residues at the terminal position of N-linked glycan chains for each lactoferrin molecule.

Poly Sialic acid plays a critical role in neural development by modulating the adhesive property of neural cell adhesion molecule and is, therefore, implicated in a wide range of morphogenic events, including cell migration, neuronal outgrowth, path-finding, sprouting, regeneration, synaptic plasticity, and serving a "reservoir function" for neurotrophic factors. Sia, a key monomeric building block of poly Sialic acid, plays crucial roles in cell-to-cell interactions, neuronal outgrowth, modifying synaptic connectivity, and memory formation An important functional property of lactoferrin is its high affinity for binding iron Iron is a ubiquitous metal that is essential for the function of all mammalian cells. Iron deficiency affects neuronal metabolism, neurotransmitter function, and myelination, which have the greatest impact on the brain during early neurodevelopment Lactoferrin is unique in that it contains 2 nutritional molecules of iron and Sialic acid, which are key components involved in early neurodevelopmental and cognitive function for infants Lactoferrin is a bifidogenic glycoprotein found in all vertebrates and mammalian milk, leukocytes, and exocrine secretions Inflammation has an adverse impact on cognition, and IL-1β, IL-6, and tumor necrosis factor alpha TNF-α are closely associated with long-term potentiation (LTP) and synaptic plasticity Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying

Study Timeline

• Study Start: 2021-09-20
• Primary Completion: 2022-09-20
• Study Completion: 2023-04-20
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• 1. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactoferrin group	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. (Asztalos.,et al 2020)

Primary Outcome Measures

Name	Time	Method
Morbidity	At 36 weeks corrected gestational age	Define any morbidities from oral lactoferrn administration
Mortality	36 corrected gestational age	To assess number of deaths in the study group
neurobehavioral outcome	at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.	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)

Secondary Outcome Measures

Name	Time	Method
effect on morbidity and mortality	at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.	effect on mortality and major morbidity at 36 weeks corrected gestational age defined as periventricular leukomalacia, necrotizing enterocolitis, and late-onset sepsis.

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Al Qahirah, Egypt