Effect of Enteral Bovine Lactoferrin in Preterm Infants
Condition: to Evaluate the Effect of Oral Administration of Bovine Lactoferrin on the Neurobehavioral Performance of Preterm Neonates
MeSH terms: Premature Birth
Study type: Interventional

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. (World Health
      Organization et al., 2015).

      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. (Karav et al., 2018).

      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. (Lonnerdal et
      al., 2011).

      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 (Wang et al., 2012).

      An important functional property of lactoferrin is its high afﬁnity for binding iron (Kumar
      et al.,2013).

      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 (Cheli et al., 2018).

      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 (Chen et al.,2015).

      Lactoferrin is a bifidogenic glycoprotein found in all vertebrates and mammalian milk,
      leukocytes, and exocrine secretions (Chahine et al.,2012).

      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
      (Özkorumak et al., 2019).

      Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying (Ochoa et al.,
      2019).
    

Intervention name(s): bovine lactoferrin
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care