Effect of Enteral Bovine Lactoferrin in Preterm Infants

Ain Shams University

Status: Completed

Conditions: Neonatal Disease

Treatments: Dietary Supplement: bovine lactoferrin

Study type: Interventional

Funder types: Other

Identifiers

NCT06015828

AinShamsUlactoferrin

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: All

Ages: 1 hour to 3 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

lactoferrin group

Experimental group

Description:

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)

Treatment:

Dietary Supplement: bovine lactoferrin

control group

No Intervention group

Description:

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