Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Test of Infant Motor Profile
研究概览
简要总结
Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.
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
- 1 Month 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy),
- •Having a NICU history of 15 days or more,
排除标准
- •congenital malformations, metabolic and genetic disease musculoskeletal system anomaly
研究组 & 干预措施
SAFE Early Intervention Group
A sensory-based, activity-focused early intervention program was implemented in an enriched environment (SAFE Early intervention). Children in the intervention group received home visits once a month and their families were coached. Families were informed about how to support their children. Home visits were made once a month for 10 weeks.
干预措施: SAFE Early İntervention (Behavioral)
SAFE Early Intervention Group
A sensory-based, activity-focused early intervention program was implemented in an enriched environment (SAFE Early intervention). Children in the intervention group received home visits once a month and their families were coached. Families were informed about how to support their children. Home visits were made once a month for 10 weeks.
干预措施: NDT based therapy (Behavioral)
Control Group
Home-based NDT program was applied to the control group. The babies in the group were examined in a clinic environment and the families were given booklets to support their children's development.
干预措施: SAFE Early İntervention (Behavioral)
Control Group
Home-based NDT program was applied to the control group. The babies in the group were examined in a clinic environment and the families were given booklets to support their children's development.
干预措施: NDT based therapy (Behavioral)
结局指标
主要结局
Test of Infant Motor Profile
时间窗: 10 weeks
High numerical scores indicate that infants notice and respond to stimuli less than their peers, meaning the infant is hypersensitive, while low numerical scores indicate that infants notice and respond to stimuli more than their peers, or are hypersensitive.
次要结局
- Infant/Toddler Sensory Profile 2(10 weeks)
- Bayley Scales of Infant and Toddler Development, Third Edition,(10 weeks)
- Infant/Toddler HOME Inventory(10 weeks)