Sleep Organization in Premature Infants With Feeding Difficulties
27 de enero de 2020 actualizado por: Children's Hospital Medical Center, Cincinnati
Babies born too soon, premature babies, can have complications following birth because their systems are immature.
Hospitals help prevent deformities and delays in motor development by using therapeutic positioning to provide containment as they would experience in the womb.
They also often have trouble eating.
They have discomfort, are irritable, refuse to eat and cry because their digestive system is immature.
The neonatal intensive unit can create stress and disrupt their sleep.
Going from active to deep sleep is essential for infant brain development, learning and memory formation.
Their sleep states early in life predict their developmental outcome.
The purpose is to determine whether a conformational positioning system, one that can mold to the baby and contain him or her, will allow more time asleep in premature infants with feeding problems compared to the standard crib mattress.
We hypothesize that the number of total sleep time will be longer and the number of arousals out of sleep lower when they are sleeping on the conformational positioning system compared to the mattress.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Premature infants are at risk for complications due to the immaturity of motor, gastrointestinal, respiratory, cutaneous and behavioral systems.
Therapeutic positioning is routinely used to provide containment, maintain a flexed position and prevent skeletal deformities and delays in motor development.
Premature infants have feeding difficulties and frequently experience gastroesophageal reflux, discomfort, refusal to feed, irritability, and crying.
The neonatal intensive care environment can create stress and disrupts sleep-wake cycles and self-regulatory behaviors.
Cycling from active to deep sleep states is required for neurosensory processing, learning, memory formation and brain plasticity.
Sleep and waking states for premature infants are predictive of neurodevelopmental outcomes.
The purpose of the study is to determine whether the use of conformational positioning will be associated with greater total sleep time in premature infants with a history feeding difficulty compared to positioning on a mattress alone.
We hypothesize that the number of arousals and total sleep time will be affected by the support surface.
Specifically, the number of arousals will be lower and total sleep time will be greater for infants when they are on a conformational positioning (CP) device compared to when they are on the standard positioning system (mattress) (SP).
The use of CP will reduce the number of arousals, increase the total sleep time, and bring about behavioral states that are conducive to regulation of attention, state and motor response relative to SP.
Tipo de estudio
Intervencionista
Inscripción (Actual)
25
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
-
-
Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
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-
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
6 meses a 8 meses (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Gestational age of < 37 weeks
- Feeding difficulty due to prematurity or a medical condition
- Not taking sedative medications for 24 hours before sleep study
- Post-surgery
- Sufficiently medically stable to undergo procedures
Exclusion Criteria:
- Gestational age equal to or greater than 37 weeks
- Clinical apnea
- Require mechanical ventilatory support
- Received sedative medications 24 hours before sleep study
- Brain injury or neurological condition that limits movement
- Orthopedic conditions requiring fixed positioning
- Arthrogryposis
- Osteogenesis imperfecta
- Medically unstable such that procedures cannot be tolerated
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: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: conformational positioner & mattress
conformational positioner & mattress, five hours on each
|
The conformational positioning system will be compared to the standard infant crib mattress.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sleep organization defined as efficiency, active sleep time, quiet sleep time, number of arousals, measured by polysomnography
Periodo de tiempo: Overnight, 10.5 hour standard EEG sleep study
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Standard polysomnography electrodes are applied to the subject in the evening and the subject is placed on either the standard mattress or the conformational positioning system (assigned at random) for the first 5 hours.
The subject is then moved onto the second treatment for the remainder of the study.
EEG measures are recorded continuously over the entire period.
The EEG data are assessed by trained sleep study physicians and clinical staff.
|
Overnight, 10.5 hour standard EEG sleep study
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sleep state by behavioral observation
Periodo de tiempo: Two 30-minute periods, one on each treatment, during the EEG sleep study
|
Nurses trained in the techniques of premature infant behavioral state determination will observe the infant for two 30-minute periods while the EEG sleep study is being conducted.
One nurse will observe when the subject is on the standard mattress and the other will observe when the subject is on the conformational positioning system.
They will record specific behaviors observed in 2-minute intervals during the 30-minute period.
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Two 30-minute periods, one on each treatment, during the EEG sleep study
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Impact of prior surgery on sleep organization
Periodo de tiempo: Overnight, 10-hour sleep study
|
Standard polysomnography electrodes are applied to the subject in the evening and the subject is placed on either the standard mattress or the conformational positioning system (assigned at random) for the first 5 hours.
The subject is then moved onto the second treatment for the remainder of the study.
EEG measures are recorded continuously over the entire period.
The EEG data are assessed by trained sleep study physicians and clinical staff.
The sleep organization and behaviorally observed sleep state will be compared for the subjects grouped as having had surgery prior to the study or not having had surgery to ascertain the impact of surgery while controlling for the treatment effects.
|
Overnight, 10-hour sleep study
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Marty O Visscher, PhD, Children's Hospital Medical Center, Cincinnati
Publicaciones y enlaces útiles
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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 septiembre de 2011
Finalización primaria (Actual)
1 de julio de 2012
Finalización del estudio (Actual)
1 de julio de 2012
Fechas de registro del estudio
Enviado por primera vez
17 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
18 de septiembre de 2013
Publicado por primera vez (Estimar)
19 de septiembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de enero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
27 de enero de 2020
Última verificación
1 de septiembre de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHMC 2011-1456
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