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A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways

22 de agosto de 2018 actualizado por: National Taiwan University Hospital

Four hypotheses will be tested in this study:

  1. The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period.
  2. The intervention group shows greater changes in early neurophysiological brain functions and transactions within the family that lead to better neurodevelopmental outcomes than the control group.
  3. Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants.
  4. Very low birth weight preterm infants carrying more genetic plasticity in the dopamine-related genes may benefit more from the interventions than those carrying less genetic plasticity.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group. Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family). The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development. In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses. The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.

Tipo de estudio

Intervencionista

Inscripción (Actual)

275

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

  • Taiwán
      • Tainan, Taiwán, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwán, 100
        • National Taiwan University Hospital
      • Taipei, Taiwán, 104
        • Mackay Memorial Hospital

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

No mayor que 8 meses (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • birth body weight < 1500 grams
  • gestational age < 37 weeks
  • parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi

Exclusion Criteria:

  • severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC)
  • congenital or chromosome abnormality
  • mother < 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol, and drug)

Terminated Criteria:

  • diagnosis of brain injury (e.g., PVL, stage IV ROP or greater)
  • severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge
  • hospital discharge beyond 44 weeks' post-menstrual age.

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Family-centered intervention program
FCIP: family members were encouraged to present in all intervention sessions included 5 in-hospital intervention, 7 after-discharge interventions (0, 1, 2, 4, 6, 9, and 12 months of corrected age), and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.
Conductual: Family-centered intervention program
This program was in-hospital intervention, after-discharge intervention, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The 7-session after-discharge intervention consisted of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education
Otros nombres:
  • FCIP
Otro: Usual care intervention program
UCP: family members were invited to present at least one session of the 5 in-hospital intervention session. Parents and infants in the UCP group received 7 after-discharge phone calls (0, 1, 2, 4, 6, 9, and 12 months of corrected age) and neonatal follow-up at 0, 1, 6, 12, 18, and 24 months of corrected age.
Conductual: Usual care intervention program
This program was in-hospital intervention, after-discharge consultation, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The after-discharge service was provided 7-phone calls for the general health consultation.
Otros nombres:
  • UCP

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Child: neurodevelopment functions (cognition, language and motor)
Periodo de tiempo: 24 months of corrected age
Bayley Scales of Infant and Toddler Development - 2nd and 3rd edition
24 months of corrected age

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of neurodevelopment functions (motor) from baseline
Periodo de tiempo: 0 months of corrected age
The Neonatal Neurobehavioral Examination-Chinese Version (NNE-C) 2. World Health Organization Quality of Life- Brief Taiwan version
0 months of corrected age
Child: neurodevelopment functions (behavior)
Periodo de tiempo: 24 months of corrected age
Child behavior checklist version 1.5-5 Y 2. World Health Organization Quality of Life- Brief Taiwan version
24 months of corrected age
Change of neurodevelopment functions (cognition, language and motor) from baseline
Periodo de tiempo: 6,12, and 24 months
Bayley Scales of Infant and Toddler Development - 3rd edition 2. World Health Organization Quality of Life- Brief Taiwan version
6,12, and 24 months
Parental functions and change from baseline (pressure)
Periodo de tiempo: 0, 6, 12, 18, and 24 months of corrected age
Parenting Stress Index 2. World Health Organization Quality of Life- Brief Taiwan version
0, 6, 12, 18, and 24 months of corrected age
Parental functions and change from baseline (Quality of Life)
Periodo de tiempo: 0, 6, 12, 18, and 24 months of corrected age
World Health Organization Quality of Life- Brief Taiwan version
0, 6, 12, 18, and 24 months of corrected age
Transactional functions and change from baseline
Periodo de tiempo: 6, 12, and 18 months of corrected age
Mother-infant interaction in free play at 6, 12, and 18 months of corrected age
6, 12, and 18 months of corrected age
Transactional functions and change from baseline
Periodo de tiempo: 6 and 12 months of corrected age
Wakeful Position Questionnaire at 6 and 12 months of corrected age
6 and 12 months of corrected age
Transactions function: affordance
Periodo de tiempo: 18 months of corrected age
1. Affordances in the Home Environment Motor Development- Chinese version
18 months of corrected age
Child: Medical data
Periodo de tiempo: Birth to 24 months of corrected age
Chart review
Birth to 24 months of corrected age
Child: growth data and change from baseline
Periodo de tiempo: 0, 1, 4, 6, 12, 18, and 24 months of corrected age
Chart review and measurement
0, 1, 4, 6, 12, 18, and 24 months of corrected age
Child: neurophysiological functions and change from baseline
Periodo de tiempo: 1 and 4 months of corrected age
Electroencephalogram/event-related potential
1 and 4 months of corrected age
Child: genotyping and gene expression
Periodo de tiempo: 0 month of corrected age
Buccal cell collection
0 month of corrected age
Parental adherence to Intervention
Periodo de tiempo: 32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months

Only assessed in FCIP group

  1. Parental motivation
  2. Goal attainment
  3. Home activity records
32-36 weeks (5 sessions), 0, 1, 2, 4, 6, 9, and 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Taiwan University Hospital

Colaboradores

National Health Research Institutes, Taiwan

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

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 (Actual)

22 de mayo de 2012

Finalización primaria (Actual)

10 de enero de 2017

Finalización del estudio (Actual)

10 de enero de 2017

Fechas de registro del estudio

Enviado por primera vez

29 de enero de 2013

Primero enviado que cumplió con los criterios de control de calidad

6 de marzo de 2013

Publicado por primera vez (Estimar)

8 de marzo de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de agosto de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

22 de agosto de 2018

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 201103075RB

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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