Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- ASQ-3 scores
研究概览
简要总结
This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Week 至 17 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.
排除标准
- •a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.
研究组 & 干预措施
Caregiver-implemented early developmental intervention (EDI) using finger puppets
Caregivers of infants in the intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
干预措施: Finger puppet (Behavioral)
Caregiver-implemented early developmental intervention (EDI) using finger puppets
Caregivers of infants in the intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
干预措施: Bookworm reading intervention training and routine EDI care. (Behavioral)
Routine EDI care including Bookworm training
All study participants will receive Bookworm reading intervention training and routine EDI care.
干预措施: Bookworm reading intervention training and routine EDI care. (Behavioral)
结局指标
主要结局
ASQ-3 scores
时间窗: 12 months corrected age
Ages and Stages Questionnaires 3rd Edition
次要结局
- ASQ-3 scores(24 months corrected age)
- MCHAT score(24 months corrected age)
- Edinburgh Postnatal Depression Scale(6 months)
- ASQ scores below -2SD(24 months corrected age)
- Severe neurodevelopmental impairment(24 months corrected age)
- Language Composite Score on BSID-IV(24 months corrected age)
- ASQ scores below -1SD(24 months corrected age)
- ASQ-SE2 scores(24 months corrected age)
- Moderate or severe neurodevelopmental impairment(24 months corrected age)
- Cognitive Composite Score on BSID-IV(24 months corrected age)
- Motor Composite Score on BSID-IV(24 months corrected age)
- ASQ scores below -2SD(12 months corrected age)
- ASQ scores below -1SD(12 months corrected age)
- ASQ-SE2 scores(12 months corrected age)
研究者
Colm Travers
Associate Professor
University of Alabama at Birmingham