- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03344991
Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Following parental consent, preterm infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are in the newborn ICU in a setting where an incubator is not available, will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer. The infants will remain in the cot or crib for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care, including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding, appropriate bundling and Kangaroo Mother Care as continuously as possible.
If at any point a babies becomes moderately (32.0-35.9° C) or severely hypothermic (< 32.0° C), an extra blanket will be added to their bodies and a hat placed on their heads.
Tipo de estudio
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Estimated gestational age < 36 6/7 weeks
- Hospitalized in the newborn ICU at University Teaching Hospital
- Nursed in an incubator for at least 24 hours
- Thought to be ready to be weaned from incubator by the clinical staff
Exclusion Criteria:
- Major congenital anomalies
- Requiring ongoing respiratory support
- Suspected sepsis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Cardboard Cot Care
Stable infant will be transferred to cardboard cot, lined with reflective film for duration of hospital stay following weaning from radiant warmer.
Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
|
When ready to be weaned from radiant warmer, infant will be placed in a reflective film-lined cot for the duration of hospitalization.
Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge.
If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature.
All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
|
Comparador de placebos: Open Crib
Stable infant will be transferred to standard of care open crib for duration of hospital stay following weaning from radiant warmer.
Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
|
When ready to be weaned from radiant warmer, infant will be placed in a standard of care open crib for the duration of hospitalization.
Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge.
If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature.
All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
Periodo de tiempo: Up to 14 days
|
Up to 14 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
Periodo de tiempo: Up to14 days
|
Up to14 days
|
Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
Periodo de tiempo: 4 months
|
4 months
|
Mean Axillary Temperatures on All Infants Weaned to Open Cribs
Periodo de tiempo: 4 months
|
4 months
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature
Periodo de tiempo: 1 hour after placement in warming device
|
1 hour after placement in warming device
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
Periodo de tiempo: 6 hours
|
6 hours
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Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
Periodo de tiempo: 24 hours after placement in warming device
|
24 hours after placement in warming device
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Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Periodo de tiempo: 1 hour after placement in warming device
|
1 hour after placement in warming device
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Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Periodo de tiempo: 6 hours after placement in warming device
|
6 hours after placement in warming device
|
Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
Periodo de tiempo: 24 hours after placement in warming device
|
24 hours after placement in warming device
|
Rate of Hyperthemia (>38° C) measured by axillary temperature
Periodo de tiempo: 14 days
|
14 days
|
Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
Periodo de tiempo: Up to 14 days
|
Up to 14 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
Otros números de identificación del estudio
- UAB Neo 019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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