Docosahexaenoic acid supplementation in preterm neonates admitted in NICU and its effect on inflammatory markers at Day 10- An open labelled Randomised controlled trail
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To measure the inflammatory markers at day 10 of admission in babies with DHA supplementation
研究概览
简要总结
Preterm neonates are deficient in long chain polyunsaturated fatty acids (LCPUFA) especially DHA. DHA transfer in uterus occurs primarily in the last trimester of pregnancy reaching peak transfer rates at 35-40 weeks of gestation to support rapid growth and brain development. When the infant is exposed to a massive environmental antigenic assualt from the birth process and neonatal intensive care unit (NICU) can result in excess inflammation and a lowered ability to down-regulate immune responses once initiated. This heightened inflammation can trigger variety of inflammatory disorders such as sepsis, Necrotizing enterocolitis, Bronchopulmonary displasia, Retinopathy of prematurity.
Therefore, there is a need to study supplementation of DHA in preterm neonates and to look whether there is any effect on inflammatory markers.
So in my study i am supplementing DHA to study group and measuring whether supplementation of DHA has effect on inflammatory markers as a primary outcome and as a secondary outcome measuring defined clinical outcomes like ( Sepsis, Retinopathy of prematurity, Necrotizing enterocolitis, bronchopulmonarydysplasia)
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •Early preterm neonates (32-34 weeks) delivered at RL Jalappa Hospital whose parents had consented to be a part in the study.
- •Clincally stable neonates to begin enteral feeding.
排除标准
- •Neonates with congenital anomalies -Neonates born to Mothers with PPROM history -Neonates with contraindication for enteral feeding -Neonates with maternal use of omega-3 supplements.
结局指标
主要结局
To measure the inflammatory markers at day 10 of admission in babies with DHA supplementation
时间窗: Day 10 of life
To compare the level of inflammatory markers between two groups
时间窗: Day 10 of life
To measure the inflammatory markers at day 10 of admission in babies without supplementation of DHA
时间窗: Day 10 of life
次要结局
- To compare the defined clinical outcomes i.e (sepsis, necrotising enterocolitis, bronchopulmonary dysplasia,and retinopathy of prematurity )(Hospital admission to discharge)