NICU Parent Education Program (NICU PEP)
2 de mayo de 2022 actualizado por: Elisabeth McGowan, Women and Infants Hospital of Rhode Island
The purpose of this study is to adminster one of two education programs to parents of preterm infants in the NICU to evaluate language and cognitive outcomes of their infants.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
- Otro: Know Your Baby Language Curriculum
- Otro: Reading Aloud Language Curriculum
- Otro: Sing A Long Language Curriculum
- Otro: Mimicking First Sounds Language Curriculum
- Otro: Language Games and Narrating Your Day Language Curriculum
- Otro: Feeding Safety
- Otro: Car Seat Safety
- Otro: Bath Safety
- Otro: Back to Sleep/SIDS prevention
- Otro: Taking a Temperature and Signs of Infection
- Otro: Infection Control Measures and Vaccine Information
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
95
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Women and Infants' Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
5 meses a 7 meses (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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).
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Early language activities that parents can do with their infants
Early language activity that parents can do with their infants
Early language activity that parents can do with their infants
Early language activity that parents can do with their infants
Early language activity that parents can do with their infants
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Comparador de placebos: 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.
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Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
Part of Health and Safety Curriculum
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bayley III cognitive composite score
Periodo de tiempo: 24 months
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Bayley III cognitive score (mean 100, standard deviation 15)
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24 months
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Bayley III language composite score
Periodo de tiempo: 24 months
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Bayley III Language score (mean 100, standard deviation 15)
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24 months
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Bayley III Expressive Language Score
Periodo de tiempo: 24 months
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Bayley III Expressive Language (mean 10, standard deviation 3)
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24 months
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Bayley III Receptive Language Score
Periodo de tiempo: 24 months
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Bayley III Receptive Language (mean 10, standard deviation 3)
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24 months
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Bayley III Motor Composite score
Periodo de tiempo: 24 months
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Bayley III Motor composite score (mean 100, standard deviation 15)
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24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Infant vocalizations Count
Periodo de tiempo: 32 weeks post menstrual age
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LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).
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32 weeks post menstrual age
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Infant vocalizations Count
Periodo de tiempo: 34 weeks post menstrual age
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LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).
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34 weeks post menstrual age
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Infant vocalizations Count
Periodo de tiempo: 36 weeks post menstrual age
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LENA recordings of infant vocalizations (software derived recording of all speech related sounds recorded in a 16 hour time period).
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36 weeks post menstrual age
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Conversational turns Count
Periodo de tiempo: 32 weeks post menstrual age
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LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period).
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32 weeks post menstrual age
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Conversational turns Count
Periodo de tiempo: 34 weeks post menstrual age
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LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period).
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34 weeks post menstrual age
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Conversational turns Count
Periodo de tiempo: 36 weeks post menstrual age
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LENA recordings of infant-parent conversational turns (softward derived recording of adult-child interactions that estimates the number of reciprocal vocalizations between infant and adult within 5 seconds, and recorded for a 16 hour time period).
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36 weeks post menstrual age
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Adult word count Count
Periodo de tiempo: 32 weeks post menstrual age
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LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).
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32 weeks post menstrual age
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Adult word count
Periodo de tiempo: 34 weeks post menstrual age
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LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).
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34 weeks post menstrual age
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Adult word count
Periodo de tiempo: 36 weeks post menstrual age
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LENA recordings of adult word count (softward derived number of adult words spoken during a 16 hour period).
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36 weeks post menstrual age
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Bayley III cognitive composite score
Periodo de tiempo: 12 month
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Bayley III cognitive score (mean 100, standard deviation 15)
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12 month
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Bayley III motor composite score
Periodo de tiempo: 12 month
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Bayley III motor score (mean 100, standard deviation 15)
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12 month
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Bayley III expressive language score
Periodo de tiempo: 12 month (mean 10, standard deviation 3)
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Bayley III expressive language score (mean 100, standard deviation 15)
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12 month (mean 10, standard deviation 3)
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Bayley III receptive language score
Periodo de tiempo: 12 month (mean 10, standard deviation 3)
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Bayley III receptive language score (mean 100, standard deviation 15)
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12 month (mean 10, standard deviation 3)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Elisabeth C McGowan, MD, Women and Infants' Hospital Providence RI
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Caskey M, Stephens B, Tucker R, Vohr B. Importance of parent talk on the development of preterm infant vocalizations. Pediatrics. 2011 Nov;128(5):910-6. doi: 10.1542/peds.2011-0609. Epub 2011 Oct 17.
- Caskey M, Stephens B, Tucker R, Vohr B. Adult talk in the NICU with preterm infants and developmental outcomes. Pediatrics. 2014 Mar;133(3):e578-84. doi: 10.1542/peds.2013-0104. Epub 2014 Feb 10.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2013
Finalización primaria (Actual)
31 de diciembre de 2020
Finalización del estudio (Actual)
31 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2015
Publicado por primera vez (Estimar)
19 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
2 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 12-0074
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Know Your Baby Language Curriculum
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