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The GROWNDUP Study of Late Preterm Births (GROWNDUP)

7 de abril de 2015 actualizado por: McMaster University

The GROWNDUP Study: Pilot to Assess the Feasibility of an RCT for Promoting Growth, Nutrition and Development Through a Specialized Late Preterm Clinic

This pilot study will examine the feasibility of conducting a large randomized clinical trial (RCT) to examine the role of a novel, specialized follow-up clinic in preventing complications among late preterm infants (LPTB), born between 34 and 36 weeks gestational age. 1) Study Process: Success will be achieved if 80% of a target population of 100 subjects is met within the first 6 months of recruitment being initiated. 2) Study Resources: Success will be achieved if 80% of follow up appointments are scheduled in a timely manner and if specialized LPTB physicians in the intervention complete assessments 75% of the time in the allocated time frame and 3) Scientific: 95% data completeness on data collection forms will be identified as success

A specialized LPTB follow-up clinic is innovative as no studies have evaluated such a programme and standardized follow-up and guidelines for the care of LPTB infants after discharge from hospital do not exist. Until recently, the incorrect assumption has been that these infants are healthy and have limited risks compared to term infants.

The study's main question, in addition to assessing the feasibility of this pilot, is: "Do differences exist in short-tem clinical and developmental outcomes among LPTB infants enrolled in an RCT who are randomized to a specialized LPTB follow-up programme when compared to infants randomized to current pragmatic management?" A RCT will provide evidence for the development of guidelines for the follow-up of LPTB infants in the first 6 months of life to reduce complications, readmissions and developmental problems.

The results of this study can be generalized to tertiary care and community hospitals and the general population.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Late preterm births comprise 70-75% of all preterm births in Ontario and 5.8% of all births in the province. These infants are at significant risk for complications but no guidelines or follow-up programmes exist for decreasing the short and long-term complications associated with LPTB. This project will lay the groundwork for gathering the research evidence to support:

  1. An RCT that will study if a specialized LPTB clinic is effective in reducing short-term medical and developmental complications and hospital readmissions,
  2. Development of a sustainable long-term follow-up programme supported by evidence,
  3. Development of a database to track long-term complications, with the goal of identifying potential risk factors earlier in late preterm infants,
  4. Creation and dissemination of Evidence-Based Guidelines, research results for frontline health care providers (GPs, Midwives, etc.), community hospitals and Local Health Integration Networks,
  5. Creation and dissemination of Parent Educational Resources for discharge of LPTB infants.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

100

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

  • Canadá
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 4A6
        • St. Joseph's Hospital
      • Hamilton, Ontario, Canadá, L8S 4K1
        • McMaster Children's Hospital & McMaster University

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 1 mes (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

- singleton or twins born at 34 and 0 days to 36 weeks and 6 days gestational age. Infants admitted to the Level 2 Nursery or newborn nursery at McMaster Children's Hospital or St. Joseph's Healthcare Hamilton or Level 3 Nursery (NICU) at McMaster Children's Hospital will be included.

Exclusion Criteria:

  • triplets and infants with major cardiac anomalies, metabolic disorders, significant gastrointestinal anomalies, intrauterine growth restriction, potential genetic syndromes, neurologic anomalies or severe sepsis/meningitis and LPTB requiring mechanical ventilation (post-delivery room resuscitation with prolonged CPAP or intubation) will be excluded.
  • mothers who have a history of substance use at any time during pregnancy or alcohol use after confirmation of pregnancy
  • participants must be able to understand English and speak English as this pilot does not currently have the financial support to sponsor interpreters.

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Current management of LPTB
The current pragmatic, but non-systematic, pattern of management of LPTB infants. Growth measurements, feeding histories/methods, illness history including emergent visits to clinicians, walk-in clinics and emergency departments and breast-feeding support clinics, and basic developmental milestones (as itemized in the Rourke Developmental screening tool) will be recorded by families and primary health care providers as itemized in the Memory Book at the assessments made at the discretion of the health care providers.
Experimental: Specialized LPTB Clinic
Additional 6 specialized LPTB follow-up clinic visits attended by pediatricians and neonatologists. Detailed findings from physical examination, feeding histories/methods, illness history including emergent visits to clinicians, walk-in clinics and emergency departments and breast-feeding support clinics, basic developmental milestones (as itemized in the Rourke Developmental screening tool) and physician recommendations will be recorded at each appointment. These will be compared to those obtained from families and primary health care providers as itemized in the Memory Book.
Otro: Specialized LPTB clinic
50% of enrolled infants will be randomized to the specialized LPTB follow-up clinic.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment Rate
Periodo de tiempo: 14 months
Recruitment Rate during first six months of pilot. Reported as the percentage of subjects recruited from those eligible to participate.
14 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Infant Weight Gain
Periodo de tiempo: 14 months
Weight Gain reported in grams.
14 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Hospital Readmission
Periodo de tiempo: 14 months
The rates of hospital readmission will be determined for the first six months of life.
14 months

Colaboradores e Investigadores

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

Patrocinador

McMaster University

Investigadores

  • Investigador principal: Lucy Giglia, MD FRCP(C) MSc, McMaster Children's Hospital & St. Joseph's Hospital

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 mayo de 2013

Finalización primaria (Anticipado)

1 de agosto de 2015

Finalización del estudio (Anticipado)

1 de agosto de 2015

Fechas de registro del estudio

Enviado por primera vez

3 de diciembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

10 de diciembre de 2012

Publicado por primera vez (Estimar)

11 de diciembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

8 de abril de 2015

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

7 de abril de 2015

Última verificación

1 de abril de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 12-156

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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