Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Neurobehavioral outcome Of the Preterm Very low birth weight babies
研究概览
简要总结
Enrolled neonates will be provided routine supportive care as per existing neonatal intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC).
详细描述
Enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B. Both the groups will receive appropriate management for their morbidities as per existing NICU protocols. Both the groups will be followed up till 37 weeks of gestation where in their neurobehavioral assessment will be performed using Neurobehavioural assessment of preterm infants score.
In both the groups all the baseline data regarding antenatal factors will be recorded in a predesigned proforma such as age, gravid, Gestational age, Chorioamnionitis, Prenatal steroids, Multiple pregnancy, maternal comorbidities (preeclampsia, gestational diabetes mellitus), mode of delivery etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 37 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All stable preterm very low birth weight babies not on invasive mechanical ventilation
- •Hemodynamically stable
- •Parental consent
排除标准
- •Babies with major congenital anomalies
- •Asphyxia (Apgar score <3 at 5mins).
- •Acute bilirubin encephalopathy
- •Hypoglycemia at enrollment
- •Clinical Chorioamnionitis(fever > 100.4 ◦ f , uterine fundal tenderness, maternal tachycardia (>100/min), fetal tachycardia (>160/min) and purulent or foul amniotic fluid )
- •History of birth trauma
研究组 & 干预措施
developmentally supportive care
enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care(DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B
干预措施: developmentally supportive care (Other)
结局指标
主要结局
Neurobehavioral outcome Of the Preterm Very low birth weight babies
时间窗: 18 months
Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age.
次要结局
- Time to achieve full feeds @150ml/kg(18 months)
- Length of hospital stay(18 months)
研究者
DR. VIKRAM DATTA
professor
Lady Hardinge Medical College
