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临床试验/NCT02817022
NCT02817022Unknown不适用

Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates

Lady Hardinge Medical College2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

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

Other

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

DR. VIKRAM DATTA

professor

Lady Hardinge Medical College

研究点 (2)

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