Genetic Variability and Biomarkers in Children With Acute Lung Injury (BALI)
Acute Lung Injury (ALI) and the more severe Acute Respiratory Distress Syndrome (ARDS) are a significant problem in Pediatric Intensive Care Units, affecting up to 16 of every 1000 children admitted to these units. These disorders carry with them high mortality rates as well as numerous long-term effects for the surviving children. As the effects of these diseases have significant social and economic ramifications for affected children and their families, research on the development of ALI/ARDS could significantly change how physicians understand the disease and treat patients.
There are a wide range of problems which make certain PICU patients more likely to develop either ALI or ARDS. This research aims to determine which of these children are at the greatest risk for ALI/ARDS by examining differences in plasma biomarkers and in DNA of a large number of PICU patients. We are hypothesizing that significant differences in the level of specific plasma biomarkers or in the frequency of specific DNA variants exist in children who develop ALI/ARDS.
Descripción general del estudio
Estado
Tipo de estudio
Contactos y Ubicaciones
Ubicaciones de estudio
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Children's Hospital of Wisconsin
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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:
- Consecutive intubated pediatric patients (≥ 2 weeks of age and ≥ 42 weeks corrected gestational age and ≤ 18 years of age) supported on mechanical ventilation for acute pulmonary parenchymal disease enrolled in the RESTORE study.
Exclusion Criteria:
- Intubated and mechanically ventilated for immediate post-operative care and stabilization
- Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
- History of single ventricle at any stage of repair
- Congenital diaphragmatic hernia or paralysis
- Primary pulmonary hypertension
- Critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
- Ventilator dependent (including noninvasive) on PICU admission (chronic assisted ventilation)
- Neuromuscular respiratory failure
- Spinal cord injury above the lumbar region
- Pain managed by patient controlled analgesia (PCA) or epidural catheter
- Family/medical team has decided not to provide full support (patient treatment considered futile)
- Enrolled in any other sedation clinical trial concurrently or within the last 30 days
- Known allergy to any of the study medications
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Non ALI/ARDS
Those patient who enrolled in the study but did not develop ALI or ARDS during their hospital course.
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ALI/ARDS
Those patients who enrolled in the study and developed ALI or ARDS during their hospital course.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Development of ALI or ARDS
Periodo de tiempo: During PICU stay
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During PICU stay
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael Quasney, PhD, MD, Medical College of Wisconsin
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
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
- Trastornos de la respiración
- Enfermedades pulmonares
- Infantil, Recién Nacido, Enfermedades
- Infantil, Prematuro, Enfermedades
- Lesiones torácicas
- Heridas y Lesiones
- Síndrome de Dificultad Respiratoria
- Síndrome de Dificultad Respiratoria, Recién Nacido
- Lesión pulmonar aguda
- Lesión pulmonar
Otros números de identificación del estudio
- 663
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