Know Your Baby Language Curriculum и Reading Aloud Language Curriculum и Sing A Long Language Curriculum при Недоношенный ребенок и Развитие языка и Результаты нейроразвития - Реестр клинических исследований

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

95

Фаза

Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Соединенные Штаты
- Rhode Island
  - Providence, Rhode Island, Соединенные Штаты, 02903
    - Women and Infants' Hospital

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 5 месяцев до 7 месяцев (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Основная цель: Профилактика
Распределение: Рандомизированный
Интервенционная модель: Параллельное назначение
Маскировка: Двойной

Количество рук

2

Оружие и интервенции

Группа участников / Армия	Вмешательство/лечение
Экспериментальный: 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).	Другой: Know Your Baby Language Curriculum Early language activities that parents can do with their infants Другой: Reading Aloud Language Curriculum Early language activity that parents can do with their infants Другой: Sing A Long Language Curriculum Early language activity that parents can do with their infants Другой: Mimicking First Sounds Language Curriculum Early language activity that parents can do with their infants Другой: Language Games and Narrating Your Day Language Curriculum Early language activity that parents can do with their infants
Плацебо Компаратор: 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.	Другой: Feeding Safety Part of Health and Safety Curriculum Другой: Car Seat Safety Part of Health and Safety Curriculum Другой: Bath Safety Part of Health and Safety Curriculum Другой: Back to Sleep/SIDS prevention Part of Health and Safety Curriculum Другой: Taking a Temperature and Signs of Infection Part of Health and Safety Curriculum Другой: Infection Control Measures and Vaccine Information Part of Health and Safety Curriculum

Группа участников / Армия

Вмешательство/лечение

Экспериментальный: 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).

Другой: Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

Другой: Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

Другой: Sing A Long Language Curriculum

Early language activity that parents can do with their infants

Другой: Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

Другой: Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

Плацебо Компаратор: 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.

Другой: Feeding Safety