Clinical trial NCT06015828: Effect of Enteral Bovine Lactoferrin in Preterm Infants
Official title: Effect of Enteral Bovine Lactoferrin on Neurobehavioral Performance of Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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.

Primary outcomes:
measure: neurobehavioral outcome
timeFrame: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
measure: Morbidity
timeFrame: At 36 weeks corrected gestational age
measure: Mortality
timeFrame: 36 corrected gestational age
Secondary outcomes:
measure: effect on morbidity and mortality
timeFrame: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: maha mohamed, PHD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: dina shinkar, PHD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: mariam ibrahim, PHD
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: mahmoud kofory, MB.,B.CH
role: PRINCIPAL_INVESTIGATOR
References: