Know Your Baby Language Curriculum 和 Reading Aloud Language Curriculum 和 Sing A Long Language Curriculum 在早产儿和语言发展和神经发育结果-临床试验注册中心-ICH GCP

研究概览

地位

完全的

条件

干预/治疗

详细说明

The long term goal of this research is to determine the language environment necessary in the NICU for very preterm infants to optimize their long-term language and cognitive development. This study will pilot an early language intervention with parents of preterm infants in the NICU the purpose of which is to provide a structured curriculum for the family to guide their language interactions with their infant. The aim is to increase the adult word counts and conversational turns in the NICU and to improve Bayley III language and cognitive scores at 12 months and 24 months corrected age.

The hypotheses is that increasing early language exposure in the NICU will result in improved lanugage and cognitive scores. The investigators plan on testing the hypothesis by the following specific aims.

Determine the effectiveness of a structured language curriculum with parents of preterm infants in the NICU on increasing the amount of early language exposure.
Test the the hypothesis that increased early language exposure will result in higher Bayley III language and cognitive scores.

研究类型

介入性

注册 (实际的)

95

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Rhode Island
  - Providence、Rhode Island、美国、02903
    - Women and Infants' Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5个月至 7个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Receiving care at Women & Infants' Hospital NICU,
Providence RI gestational age 23 - 32 weeks,
RI resident

Exclusion Criteria:

Unable to understand or speak English,
congenital or chromosomal disorder likely to affect cognitive or speech development,
parental loss of custody

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：预防
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

2

武器和干预

参与者组/臂	干预/治疗
实验性的：Language Curriculum The Language Intervention group will receive some of the known methods for early language development. Six lessons will include: Knowing your Baby, Reading Aloud, Sing-A-Long, Mimicking First Sounds, Language Game and Narrating Your Day. Parents will receive feedback every 2 weeks from a Language Environment Analysis digital language processor (LENA).	其他：Know Your Baby Language Curriculum Early language activities that parents can do with their infants 其他：Reading Aloud Language Curriculum Early language activity that parents can do with their infants 其他：Sing A Long Language Curriculum Early language activity that parents can do with their infants 其他：Mimicking First Sounds Language Curriculum Early language activity that parents can do with their infants 其他：Language Games and Narrating Your Day Language Curriculum Early language activity that parents can do with their infants
安慰剂比较：Health and Safety Curriculum Parents will receive six lessons on important infant safety topics including, feeding safety, care seat safety, bath safety, back to sleep/SIDS prevention, taking a temperature and signs of infection, infection control methods and vaccine information. Parents will receive LENA feedback at discharge from NICU.	其他：Feeding Safety Part of Health and Safety Curriculum 其他：Car Seat Safety Part of Health and Safety Curriculum 其他：Bath Safety Part of Health and Safety Curriculum 其他：Back to Sleep/SIDS prevention Part of Health and Safety Curriculum 其他：Taking a Temperature and Signs of Infection Part of Health and Safety Curriculum 其他：Infection Control Measures and Vaccine Information Part of Health and Safety Curriculum

参与者组/臂

干预/治疗

实验性的：Language Curriculum

The Language Intervention group will receive some of the known methods for early language development. Six lessons will include: Knowing your Baby, Reading Aloud, Sing-A-Long, Mimicking First Sounds, Language Game and Narrating Your Day. Parents will receive feedback every 2 weeks from a Language Environment Analysis digital language processor (LENA).

其他：Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

其他：Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

其他：Sing A Long Language Curriculum

Early language activity that parents can do with their infants

其他：Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

其他：Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

安慰剂比较：Health and Safety Curriculum

Parents will receive six lessons on important infant safety topics including, feeding safety, care seat safety, bath safety, back to sleep/SIDS prevention, taking a temperature and signs of infection, infection control methods and vaccine information. Parents will receive LENA feedback at discharge from NICU.

其他：Feeding Safety