Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of patients where treatment was initiated within 48 hours
研究概览
简要总结
This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
详细描述
Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. Based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in HIE neonates. Improving neurodevelopmental outcomes of newborns with HIE has been an intense area of research over the past decade.
Breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. Studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. Animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. In preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated.
In this prospective study our aim is to assess the feasibility and safety of intranasally delivered breast milk to HIE infants treated with hypothermia. Our objective is to administer fresh, own-mother's breast milk intranasally to neonates with HIE starting from the first day of life and continuing for 1 month.
Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk expressed within 4 hours and continuing treatment after discharge until day 28. Safety will be assessed through monitoring vital signs and documenting any adverse events. Time to reach full enteral feeding and lengths of exclusive breast feeding will be recorded and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia
- •gestational week
- •< 48 hours of life
- •Hypothermia treatment for 72 hours
- •Parental consent form
排除标准
- •Congenital malformation
- •Concurrent cerebral lesions
- •ECMO therapy
- •Contraindication of lactation
- •Mother unable or unwilling to provide fresh breast milk
- •Postpartum asphyxia
研究组 & 干预措施
Intranasal breast milk
Study participants receive their own mother's fresh breast milk, expressed within 4 hours, administered 2 times daily, 0.4 ml in each nostril for 28 days.
干预措施: Intranasal breast milk (Biological)
结局指标
主要结局
Proportion of patients where treatment was initiated within 48 hours
时间窗: 1 months
Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk.
次要结局
- Number of adverse events associated with breast milk administration(1 month)
- Time to reach full enteral feeding(1 month)
- Length of exclusive breast feeding(2 years)
- Total number of treatments during first months of life(1 months)