Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome (AA NAS)
Efficacy of Auricular Acupuncture on Neonatal Abstinence Syndrome: A Randomized Controlled Trial
This study will assess the efficacy of needle auricular acupuncture (AA) in neonatal abstinence syndrome (NAS) infants who require pharmacologic therapy at the Tampa General Hospital NICU. The investigators will evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.
This is the first study to evaluate efficacy of needle AA as an adjunct treatment for NAS by means of total methadone dose exposure, peak withdrawal scores, and overall length of stay.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Enrolled infants will be randomized to a control group and an acupuncture group.
The control group will receive nonpharmacologic and pharmacologic management as per our current standard of care.
The acupuncture group will additionally receive AA. Once the infant is enrolled, he/she will be randomized to the AA group or the control group. Both groups of randomized infants will be taken daily to a designated treatment room. Infants in the control group will not receive acupuncture, and will only receive observation in the treatment room and will have review of their EMR.
If in the AA group, the investigator will evaluate the infant using an ear point locator to determine active sites prior to each needle placement. Acupuncture infants will have needles placed in any active sites found in one ear (up to 5 needles). Acupuncture sites will be alternated daily between right and left ear.
Acupuncture will be discontinued on the same day as methadone is discontinued, or if infant is cleared to be discharged home on methadone, acupuncture is discontinued when infant reaches the discharge dose of methadone.
Data for both groups will be collected on the day of enrollment, every three days during study participation, and at hospital discharge.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33606
- USF Health
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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:
- Gestational age ≥ 35 0/7 weeks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate
- Admitted to the TGH Transition Nursery or NICU with a diagnosis of NAS, or maternal / infant positive urine drug screen result
- May have any of the following additional diagnoses at the time of admission: late prematurity, hyperbilirubinemia, hypoglycemia, sepsis without hypotension, respiratory distress without requiring support, or temperature instability
- Parents give written consent prior to starting pharmacologic treatment for NAS
- AA needles are placed within 9 hours of infant's initial NICU Finnegan score >4
Exclusion Criteria:
- Helix or antihelix of ear is deformed and needle is unable to be placed
- Skin condition around the ear
- A suspected or confirmed genetic or metabolic syndrome
- Department of Children and Families investigation results in termination of parental rights
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Auricular Acupuncture
Study subjects randomized to this group will receive auricular acupuncture: the investigator will evaluate the infant using an ear point locator to determine active sites, and will place acupuncture needles in the active sites found in one ear.
Acupuncture sites will be alternated every 3 days between right and left ear.
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Sin intervención: Control
The subjects randomized to the control group will have NO interventions, and will continue to receive routine care for NAS, pharmacologic and non-pharmacologic, per NICU protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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The number of infants requiring / starting methadone
Periodo de tiempo: Up to 5 days
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Up to 5 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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cumulative total amount of methadone exposure
Periodo de tiempo: up to two months
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up to two months
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total length of hospital stay
Periodo de tiempo: duration of hospital stay
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duration of hospital stay
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peak single finnegan score after treatment initiation
Periodo de tiempo: within first two weeks
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within first two weeks
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Peak dose of methadone required after initial AA treatment
Periodo de tiempo: within the first two weeks
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within the first two weeks
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average modified finnegan neonatal abstinence severity score for CNS symptoms
Periodo de tiempo: Up to two months
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Up to two months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Maya Balakrishnan, MD, USF Health Pediatrics / Neonatology
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
Otros números de identificación del estudio
- IRB#Pro00025881
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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Ensayos clínicos sobre Auricular acupuncture
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