Effect of Enteral Bovine Lactoferrin on Neurobehavioral Performance of Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded randomized controlled trial Neonates will be randomized using closed envelopes into two groups
入排标准
- 年龄范围
- 1 Hour 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable preterm neonates
- •gestational age less than 35 weeks
- •younger than 72 hours at randomization
- •have initiated enteral feds.
排除标准
- •Neonates with underlying gastrointestinal problems that prevent oral intake.
- •Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities,
- •structural brain anomalies,
- •severe congenital abnormalities).
- •Neonates with a history of perinatal hypoxia.
- •Neonates with a family background of cow milk allergy.
- •Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake.
结局指标
主要结局
Mortality
时间窗: 36 corrected gestational age
To assess number of deaths in the study group
Morbidity
时间窗: At 36 weeks corrected gestational age
Define any morbidities from oral lactoferrn administration
neurobehavioral outcome
时间窗: 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)
次要结局
- effect on morbidity and mortality(at 36 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer.)
研究者
Mariam Ibrahim
assistant professor of pediatrics, Ian shams university
Ain Shams University