Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

Официальное название

The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study

Обзор

This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.

Подробное описание

The purpose of this exploratory pilot study is to learn what, if any, effects live music therapy interventions have on the pacification, stabilization, and development of infants diagnosed with Neonatal Abstinence Syndrome (NAS). Neonatal Abstinence Syndrome is a group of problems that occur in a newborn who has been exposed to illegal or prescription opiates while in the mother's womb. Participants will receive 6 music therapy sessions over a 14-day period based on a randomized treatment schedule of 6 different interventions.

Вмешательства

• Поведенческое Song of Kin
  Music therapists will assess meaningful song/theme (of choice/culture) and provide musical elements in a way that nurtures parents. They will then develop a simplified part of the theme into a soothing lullaby for their infants to be utilized directly by the parent/s and/or the music therapist to comfort, engage or sedate.
• Другое Gato box
  Depending on the time of intervention and need of the infant the music therapist will provide rhythmic entrainment that follows the heart rate or suck patterns of the infant
• Другое Ocean disc
  Depending on the time of intervention and needs of the infant the music therapist will provide a whoosh sound using the Remo Ocean disc. It will be entrained to the infant's respiratory rate.
• Другое Contingent singing
  Depending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep
• Другое Tonal Vocal holding
  Music therapist will provide a vowel, long held tone, sung without vibrato
• Другое Muted shaker
  If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate

Первичные конечные точки

• Heart Rate [Срок оценки: up to 2 weeks]
• Respiratory Rate [Срок оценки: up to 2 weeks]
• O2 sats [Срок оценки: up to 2 weeks]
• Activity level [Срок оценки: up to 2 weeks]
• Sleep category [Срок оценки: up to 2 weeks]
• Feeding (sucking and absorption) category [Срок оценки: up to 2 weeks]
• Neonatal Abstinence Scoring (NAS) [Срок оценки: up to 2 weeks]

Вторичные конечные точки (1)

• Postpartum Bonding Questionnaire (PBQ ) [Срок оценки: Baseline]

Критерии участия

Критерии включения

Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender:

• Admitted to the NICU immediately postpartum
• Gestational age 28 weeks or older
• No identified hearing disorder
• Do not have a diagnosed developmental disability (i.e. Down Syndrome)
• Do not have Fetal Alcohol Syndrome
• Medically cleared to participate in the study by nurse or neonatologist
• Parent or legal guardian able/willing to give consent \& complete the PBQ (Postpartum Bonding Questionnaire)

Критерии исключения

• Admitted to the NICU at any time other than immediately postpartum
• Gestational age <28 weeks old
• Has an identified hearing disorder
• Has diagnosed developmental disability (i.e. Down syndrome)
• Has Fetal Alcohol Syndrome
• Is not medically cleared to participate in the study by the nurse or neonatologist
• Parent or legal guardian unable/unwilling to give consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Tulane University Hospital — New Orleans
• Joseph M. Sanzari Children's Hospital — Hackensack
• Northwell Health — New Hyde Park
• Mount Sinai West — New York
• Maria Fareri Children's Hospital — Valhalla
• Drexel University/Hahnemann Hospital-College of Nursing and Health Professions — Philadelphia

Публикации

• Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15. PMID 23589814
• Loewy J. NICU music therapy: song of kin as critical lullaby in research and practice. Ann N Y Acad Sci. 2015 Mar;1337:178-85. doi: 10.1111/nyas.12648. PMID 25773633
• Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25. PMID 27561729
• Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2. PMID 33348423

Идентификаторы

NCT: NCT03533985 · GCO 16-1991 · IRB 16-00740

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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