A Randomized Controlled Trial to Asess the Effectiveness of Nurse Led Developmental Intervention Packages on Neurodevelopmental Outcome of Preterm babies in AIIMS, Jodhpur.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The outcome variables are cognitive, motor development, language development and social –emotional development of preterm babies at 9-months corrected age as it is assessed by Bayley Scales of Infant and Toddler Development Third Edition.
研究概览
简要总结
This is a Randomized, open-label, parallel-group single-center trial to compare the efficacy of Nurse-Led developmental intervention packages on the neurodevelopmental outcome of preterm babies in AIIMS, Jodhpur at 9 months of corrected age among 220 preterm babies born less than 36 weeks of gestational age admitted in NICU. The primary outcome of the study is cognitive, motor, language, and socioemotional development of preterm babies as assessed by Bayley Infant and Toddler developmental scale, Edition III at 3 months, 6 months and 9 months follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Month(s) 至 9.00 Month(s)（—）
- 性别
- All
入选标准
- •Babies born Less than 36 weeks of GA.
- •Babies who are admitted to the AIIMS hospital Jodhpur
- •Preterm baby admitted in NICU for more than 5 days.
排除标准
- •Preterm babies with congenital anomalies and who require surgical treatment at birth.
- •TORCH Infection
- •Inborn Error of Metabolism.
结局指标
主要结局
The outcome variables are cognitive, motor development, language development and social –emotional development of preterm babies at 9-months corrected age as it is assessed by Bayley Scales of Infant and Toddler Development Third Edition.
时间窗: 3 Months 6 Months and 9 Months corrected age
次要结局
- 1. Factors associated with Neurodevelopmental outcome of preterm babies(2. Parental satisfaction with Neurodevelopmental supportive care.)