Know Your Baby Language Curriculum e Reading Aloud Language Curriculum e Sing A Long Language Curriculum em Recém-nascido prematuro e Desenvolvimento da linguagem e Resultados do Neurodesenvolvimento - Registro de Ensaios Clínicos

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

95

Estágio

Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Estados Unidos
- Rhode Island
  - Providence, Rhode Island, Estados Unidos, 02903
    - Women and Infants' Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

5 meses a 7 meses (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Prevenção
Alocação: Randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Dobro

Número de braços

2

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Experimental: 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).	Outro: Know Your Baby Language Curriculum Early language activities that parents can do with their infants Outro: Reading Aloud Language Curriculum Early language activity that parents can do with their infants Outro: Sing A Long Language Curriculum Early language activity that parents can do with their infants Outro: Mimicking First Sounds Language Curriculum Early language activity that parents can do with their infants Outro: Language Games and Narrating Your Day Language Curriculum Early language activity that parents can do with their infants
Comparador de Placebo: 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.	Outro: Feeding Safety Part of Health and Safety Curriculum Outro: Car Seat Safety Part of Health and Safety Curriculum Outro: Bath Safety Part of Health and Safety Curriculum Outro: Back to Sleep/SIDS prevention Part of Health and Safety Curriculum Outro: Taking a Temperature and Signs of Infection Part of Health and Safety Curriculum Outro: Infection Control Measures and Vaccine Information Part of Health and Safety Curriculum

Grupo de Participantes / Braço

Intervenção / Tratamento

Experimental: 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).

Outro: Know Your Baby Language Curriculum

Early language activities that parents can do with their infants

Outro: Reading Aloud Language Curriculum

Early language activity that parents can do with their infants

Outro: Sing A Long Language Curriculum

Early language activity that parents can do with their infants

Outro: Mimicking First Sounds Language Curriculum

Early language activity that parents can do with their infants

Outro: Language Games and Narrating Your Day Language Curriculum

Early language activity that parents can do with their infants

Comparador de Placebo: 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.

Outro: Feeding Safety