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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
80
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.
Ain Shams University Hospitals
Cairo, Cairo Governorate, Egypt
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)
Time frame: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
Morbidity
Define any morbidities from oral lactoferrn administration
Time frame: At 36 weeks corrected gestational age
Mortality
To assess number of deaths in the study group
Time frame: 36 corrected gestational age
effect on morbidity and mortality
effect on mortality and major morbidity at 36 weeks corrected gestational age defined as periventricular leukomalacia, necrotizing enterocolitis, and late-onset sepsis.
Time frame: at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.
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