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临床试验/NCT03688386
NCT03688386Unknown不适用

Bridging Connections: A Language Intervention Study of Preterm Infants in the NICU

Women and Infants Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2018年12月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
67
试验地点
2
主要终点
LENA Counts

研究概览

简要总结

This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.

详细描述

This project aims to examine how an educational reading intervention in the NICU can impact preterm infant language development and examine the impact of reading on mother-infant autonomic systems. Investigators plan to determine the effects of parent reading in addition to standard caretaking and holding on preterm infants, between 23 to 31 weeks gestation hospitalized in the Women & Infants NICU, on adult word count, infant vocalizations, conversational turns through audio recording obtained over 3 separate days when the infant is corrected to 32, 34 and 36 weeks. Investigators aim to determine the effect of parent reading on maternal and infant heart rate variability before, during, and after the shared reading intervention through video and a single channel electrocardiographic recording over the same 3 separate days as the LENA recording. Additionally, investigators aim to determine the effect of parent reading on maternal stress and perceived well-being in the NICU through a validated questionnaire and to determine parent satisfaction of a NICU reading intervention through a parent questionnaire completed prior to infant discharge and at the 12 month follow up visit. Secondary outcomes include determining the effect of parent reading on infant DNA methylation of the several genes through two saliva samples collected from the infant prior to study and post study enrollment and examine its relationship with infant stress and self-regulation based on a neurobehavioral exam performed at 36 weeks corrected age. Final outcomes include examination of the long-term effect of inpatient shared reading education on infant receptive and expressive language development at 12 and 24 months. Investigators hope this research will contribute to the growing research supporting early language development in preterm infants and its impact on maternal-infant well-being.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
23 Weeks 至 31 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 21-31 week infants, medically stable infants, English speaking mothers over 18 years old

排除标准

  • Intubated or medically unstable, major congenital anomalies, non English speaking

结局指标

主要结局

LENA Counts

时间窗: Change from 32 week language counts to 36 week language counts

Adult word counts, conversational turns, and infant vocalizations from each recording

次要结局

  • Perception of reading and infant bonding(36 weeks and 12 months)
  • Neonatal Intensive Care Unit Network Neurobehavioral Scale profile(36 weeks)
  • Maternal Well-Being(36 weeks)
  • Bayley Scales of Infant and Toddler Development, Third Edition(12 months and 24 months)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Sponsor

研究点 (2)

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