Assessment of Lung Structure and Function of Infants Born Prematurely
Descripción general del estudio
Estado
Condiciones
Descripción detallada
SPECIFIC AIM #1:
Determine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life.
We hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.
SPECIFIC AIM #2:
Determine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.
We hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Riley Hospital for Children
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Group 1:
- 37 weeks or greater gestational age
- Age 2 to 36 months
Group 2:
- 37 weeks or greater gestational age having a CT scan for non-respiratory issues.
- Age 2-36 months
Group 3:
- 23-35 weeks gestational age
Exclusion Criteria:
Group 1 and Group 2:
- Congenital cardio-respiratory disease
- Hospitalization for respiratory illness
- Treatment with asthma medications
- Small for gestational age at birth
Group 3:
- Congenital cardio-respiratory disease
- Severe developmental delay
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
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1-Healthy Infants
Group 1: The investigators will recruit 80 healthy infants born at > 37 weeks gestation, and between 2 and 36 months of age. Infants will be excluded for any of the following reasons:
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2-Healthy Infants computerized Tomography
Group 2: The investigators recruited 4 infants born at > 37 weeks gestation and they were evaluated between 2 and 36 months of age when scheduled for high resolution computed tomography (HRCT) imaging for non-respiratory medical problems. Subjects were enrolled and HRCT of the chest were obtained. Infants were excluded for the following reasons:
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3-Premature Infants
Group 3: The investigators have recruited 45 infants born prematurely at 23-35 weeks gestation. Subjects were evaluated at corrected age at between 2 and 24 months. The subjects had no oxygen requirements, and were clinically stable outpatients when evaluated. Infants were excluded for any of the following reasons:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pulmonary Function Testing
Periodo de tiempo: day of testing
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Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume
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day of testing
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert S. Tepper, MD, PhD, Indiana University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Infantil, Recién Nacido, Enfermedades
- Complicaciones del embarazo
- Complicaciones obstétricas del parto
- Trabajo de parto prematuro, obstétrico
- Lesión pulmonar
- Infantil, Prematuro, Enfermedades
- Lesión pulmonar inducida por ventilador
- Nacimiento prematuro
- Displasia broncopulmonar
Otros números de identificación del estudio
- 0603-15
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