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临床试验/CTRI/2024/07/071674
CTRI/2024/07/071674已完成不适用

Effectiveness Of The SAFE Early Intervention Approach On Neurodevelopment In Preterm Infants With Abnormal Fidgety Movements: Randomized Controlled Trial

Shruti Desai1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
General Movement Assessment tool

研究概览

简要总结

Objective: To evaluate the effectiveness of SAFE early intervention on Neurodevelopment in preterm infants with abnormal fidgety movements using the Ages and Stages Questionnaire-3 (ASQ-3). 

Inclusion: Male and female infants born before 37 weeks of gestational age; between 2-3 months of age; with abnormal fidgety movements

Exclusion: Having a history of congenital anomaly or systemic disease; Dependence on oxygen; h/o seizures.

研究设计

研究类型
Interventional

入排标准

年龄范围
2.00 Month(s) 至 3.00 Month(s)(—)
性别
All

入选标准

  • Male and female infants born before 37 weeks of gestational age. Infants between 2 months.
  • 3 months (2 months 0 days- 2 months 30 days) of corrected age. Preterm infants having abnormal fidgety movements. Willingness of family members to participate in this study. Score less than 10 on Edinburgh postnatal depression scale.

排除标准

  • Having a history of congenital anomaly or systemic disease.
  • Medical conditions which prevent active participation in therapy (such as dependence on oxygen).
  • H/O Seizures.

结局指标

主要结局

General Movement Assessment tool

时间窗: Baseline Screening

次要结局

  • Ages and Stages Questionnaire, Third Edition(Baseline and Post intervention)

研究者

发起方
Shruti Desai
申办方类型
Other [self sponsored]
责任方
Principal Investigator
主要研究者

Shruti Desai

KAHER Institute of Physiotherapy

研究点 (1)

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