Aplicación para predecir la apnea neonatal con bradicardia (APNeA)
Aplicación para predecir la apnea neonatal con bradicardia (estudio de apnea)
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This will be a randomized cross-over trial that will use additional ECG leads connected to a novel device and laptop to determine the accuracy and efficacy of an algorithm to predict, detect, and interrupt episodes of bradycardia for two 4-hour periods. There will be a 4-hour period without vibro-tactile stimulation and a 4-hour period with vibro-tactile stimulation when episodes are predicted or detected.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rachel L. Benz, Clinical Research Nurse Manager, MSN
- Número de teléfono: 205-934-2184
- Correo electrónico: rlbenz@uabmc.edu
Copia de seguridad de contactos de estudio
- Nombre: Kimberly M. Armstead Clinical Research Coordinator III, B.S.
- Número de teléfono: 205-934-0095
- Correo electrónico: karmstead@uabmc.edu
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35209
- Reclutamiento
- University of Alabama at Birmingham
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Contacto:
- Kimberly M. Armstead Clinical Research Coordinator III, B.S.
- Número de teléfono: 205-934-0095
- Correo electrónico: karmstead@uabmc.edu
-
Contacto:
- Rachel L Benz Clinical Research Nurse Manager, MSN
- Número de teléfono: 205-934-2184
- Correo electrónico: rlbenz@uabmc.edu
-
Investigador principal:
- Colm P. Travers, M.D.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Documented episodes of apnea with bradycardia over the previous 24 hours.
- Off ventilatory support/NCPAP for > 48 hours prior to study entry
- Gestational age < 32 0/7 weeks' gestation at birth
- Parents/legal guardians have provided consent for enrollment
Exclusion Criteria:
- a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Virbrotactile stimulation
Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected. |
Vibro-Tactile stimulation when bradycardia is predicted or predicted. |
|
Comparador falso: Control
Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected. |
Sham closed-loop vibrotactile stimulator |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bradycardia <100 beats per minute ≥ 10 seconds
Periodo de tiempo: 4-hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period. |
4-hours on either intervention.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bradycardia <60 beats per minute ≥ 5 seconds
Periodo de tiempo: 4 hours in either intervention.
|
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 5 seconds) in either study arm during the study period. |
4 hours in either intervention.
|
|
Bradycardia <60 beats per minute ≥ 10 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Bradycardia <80 beats per minute ≥ 5 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Bradycardia <80 beats per minute ≥ 10 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Proportion of time with Bradycardia < 100 beats per minute
Periodo de tiempo: 4 hours on either intervention.
|
The total proportion of time with bradycardia during the study period on either intervention with a heartrate of <100 beats per minute. |
4 hours on either intervention.
|
|
Hypoxemia <85% for ≥ 5 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
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Hypoxemia <85% for ≥ 10 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <90% for ≥ 5 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <90% for ≥ 10 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <80% for ≥ 5 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <80% for ≥ 10 seconds
Periodo de tiempo: 4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Proportion of time with hypoxemia < 90%
Periodo de tiempo: 4 hours on either intervention.
|
The total proportion of time with oxygen saturations <90% during the study period on either intervention. |
4 hours on either intervention.
|
|
Bradycardia prediction time
Periodo de tiempo: 4 hours on either intervention.
|
The number of seconds ahead of routine patient monitors at which the device algorithm predicted bradycardia in either group. |
4 hours on either intervention.
|
|
Bradycardia prediction accuracy
Periodo de tiempo: 4 hours on sham control.
|
The area under the curve for the true prediction rate over the false alarm rate in the control group. |
4 hours on sham control.
|
|
Proportion of time with hypoxemia < 85%
Periodo de tiempo: 4 hours on either intervention.
|
The total proportion of time with oxygen saturations <85% during the study period on either intervention. |
4 hours on either intervention.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Colm P. Travers Associate Professor of Pediatrics, M.D., University of Alabama at Birmingham
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- 300008477
- UAB (Otro identificador: UAB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Deidentified individual participant data will be made available upon publication through a data use agreement to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to cptravers@uabmc.edu.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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.
producto fabricado y exportado desde los EE. UU.
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