Effect of Coconut oil massage versus Sunflower oil massage on the weight gain velocity in preterm neonate - A Randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the effect of coconut oil massage on weekly weight gain velocity and cumulative weight gain over four weeks with that of Sunflower oil in preterm neonates
研究概览
简要总结
Newborn oil massage is a traditional practice that acts by protecting skin barrier functions, thereby reducing trans epidermal water losses and conserving energy to promote overall growth.
Topical emollient therapy with coconut oil or sunflower oil is safe and effective in reducing skin trauma in preterm infants. Evidence of in facility weight gain with oil massage therapy with the specific type of emollient in extreme and very preterm , extremely low birth weight and very low birth weight babies is deficient. Coconut and sunflower oil both being easily available with minimum cost constraints are planned to compare so as to assess their effect on the weight gain velocity in the two groups of neonates. These two are only chosen as they both are comparable in terms of cost with its ease of availability especially in LMIC. Moreover, sunflower oil is known for its high content of mono and polyunsaturated fatty acid, particularly omega 6 fatty acids. It is also rich in vitamin A,E,D,C which are essential antioxidants. Whereas, coconut oil is rich in saturated fatty acid content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All hemodynamically stable neonates between 28 weeks to 34+6 weeks of gestation will be enrolled at 72 hours of birth.
排除标准
- •Babies with major congenital malformation Refusal to give consent Generalised skin disorders and local skin burns Ecchymosis m soft tissue injury or bleeding tendencies Hydrops Mechanical ventilation with map more than 7 or High Frequency ventilation Presence of fracture IVH grade 2 or more at enrolment Hemodynamically unstable with more than 2 inotropes Intercostal tube drainage in situ at enrolment.
结局指标
主要结局
To compare the effect of coconut oil massage on weekly weight gain velocity and cumulative weight gain over four weeks with that of Sunflower oil in preterm neonates
时间窗: 28 days of life or death
次要结局
- Biochemical parameters(1. Biochemical parameters of bone health ( calcium , Phosphorus,Alkaline phosphatase, Tubular re absorption of phosphate, Parathyroid hormones , Triglycerides, vitamin D levels))
研究者
Souradip Banik
National Institute of Medical Sciences and Research , Jaipur, Rajasthan