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临床试验/NCT06930482
NCT06930482已完成不适用

Effect of SAFE Early Intervention Program on Neurodevelopmental Outcomes At 1 Year of Age in Infants at Risk of CP

Gazi University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Bayley Scales of Development for Infants and Toddlers III (Bayley-III)

研究概览

简要总结

In this study, it was aimed to examine the effect of SAFE, which is a sensory-based, activity-oriented early intervention approach applied in an enriched environment with family cooperation, on cognitive, language, motor and sensory development in 3-6 months old risky infants. 46 infants with neurodevelopmental risk, whose corrected age was 3 months, were included in the study. Infants were randomly divided into two groups. Infants in the treatment group were included in an early intervention program according to the SAFE approach. Infants in the control group were included in the family education program based on the principles of Neurodevelopmental Therapy (NDT). The intervention was performed for 12 weeks, and all infants were evaluated with Bayley Developmental Scale for Infants and Young Children III (Bayley III) by a blinded investigator before treatment (3rd months) after treatment (6th months) and 12th months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Corrected age of 3 months
  • Any neurodevelopmental risk (perinatal stroke, perinatal asphyxia, HIE, GMK-IVK, PVL or gestational age of 32 and below)

排除标准

  • Having a congenital anomaly
  • Having a genetic syndrome diagnosis (e.g. Down Syndrome)
  • Parents do not speak Turkish

结局指标

主要结局

Bayley Scales of Development for Infants and Toddlers III (Bayley-III)

时间窗: 3 months,6 months, 12 months

次要结局

未报告次要终点

研究者

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

Ayse Simsek

Principal Investigator

Gazi University

研究点 (1)

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