Effect of Music Therapy on Infants with Neonatal Abstinence Syndrome

Not Applicable

Recruiting

• Conditions: NAS

• Registration Number: NCT03533985
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-11
• Study First Posted: 2018-05-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
O2 sats	up to 2 weeks	Oxygen saturation levels (O2 sats)
Heart Rate	up to 2 weeks
Feeding (sucking and absorption) category	up to 2 weeks	The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
Neonatal Abstinence Scoring (NAS)	up to 2 weeks	The NAS score lists 21 symptoms that are most frequently observed in opiate-exposed infants. Each symptom and its associated degree of severity are assigned a score and the total abstinence score is determined by totalling the score assigned to each symptom over the scoring period. Please provide the full scale info (example 0 (no symptoms) to 10 (severe symptoms)
Sleep category	up to 2 weeks	The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
Activity level	up to 2 weeks	The neonatologist or nurse will assess and mark as active/alert, active to stimulation, flaccid, hypertonic, hypotonic, irritable, jittery, lethargic, paralyzed\&medicated, quiet, sedated, or tremors
Respiratory Rate	up to 2 weeks

Secondary Outcome Measures

Name	Time	Method
Postpartum Bonding Questionnaire (PBQ )	Baseline	Questionnaire to assess capacity for attachment in both mothers and fathers. 25 item scale with each item rated from always to never. Scoring is based on four categories: impaired bonding scores 0-60, rejection and pathological anger scores 0-35, infant-focused anxiety scores 0-20, and incipient abuse scores 0-10. Total range from 0 (good bonding) to 125 (poor bonding).

Trial Locations

Locations (6)

Tulane University Hospital; 🇺🇸 New Orleans, Louisiana, United States

Joseph M. Sanzari Children's Hospital; 🇺🇸 Hackensack, New Jersey, United States

Northwell Health; 🇺🇸 New Hyde Park, New York, United States

Mount Sinai West; 🇺🇸 NY, New York, United States

Maria Fareri Children's Hospital; 🇺🇸 Valhalla, New York, United States

Drexel University/Hahnemann Hospital-College of Nursing and Health Professions; 🇺🇸 Philadelphia, Pennsylvania, United States