Know Your Baby Language Curriculum と Reading Aloud Language Curriculum と Sing A Long Language Curriculum で未熟児と言語発達と神経発達の転帰-臨床試験登録-ICH GCP

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

95

段階

適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

アメリカ
- Rhode Island
  - Providence、Rhode Island、アメリカ、02903
    - Women and Infants' Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

5ヶ月～7ヶ月 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：防止
割り当て：ランダム化
介入モデル：並列代入
マスキング：ダブル

アーム数

2

武器と介入

参加者グループ / アーム	介入・治療
実験的：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).	他の：Know Your Baby Language Curriculum Early language activities that parents can do with their infants 他の：Reading Aloud Language Curriculum Early language activity that parents can do with their infants 他の：Sing A Long Language Curriculum Early language activity that parents can do with their infants 他の：Mimicking First Sounds Language Curriculum Early language activity that parents can do with their infants 他の：Language Games and Narrating Your Day Language Curriculum Early language activity that parents can do with their infants
プラセボコンパレーター：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.	他の：Feeding Safety Part of Health and Safety Curriculum 他の：Car Seat Safety Part of Health and Safety Curriculum 他の：Bath Safety Part of Health and Safety Curriculum 他の：Back to Sleep/SIDS prevention Part of Health and Safety Curriculum 他の：Taking a Temperature and Signs of Infection Part of Health and Safety Curriculum 他の：Infection Control Measures and Vaccine Information Part of Health and Safety Curriculum

参加者グループ / アーム

介入・治療

実験的：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).

他の：Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

他の：Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

他の：Sing A Long Language Curriculum

Early language activity that parents can do with their infants

他の：Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

他の：Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

プラセボコンパレーター：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.

他の：Feeding Safety