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临床试验/NCT06335524
NCT06335524招募中不适用

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2024年11月1日最近更新:
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适应症

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
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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 Day 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.

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

  • Edinburgh Postnatal Depression Scale(6 months)
  • ASQ scores below -2SD(24 months corrected age)
  • ASQ-3 scores(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)
  • MCHAT score(24 months corrected age)

研究者

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

Colm Travers

Associate Professor

University of Alabama at Birmingham

研究点 (2)

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Infant-Maternal Partnership and Cognitive Training... | 临床试验