Study Summary
This trial is looking at whether music therapy can help newborns with opioid withdrawal syndrome by reducing symptoms and resource use.
- Neonatal Abstinence Syndrome
- Neonatal Substance Withdrawal
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
6 Primary · 0 Secondary · Reporting Duration: Change in phase of sleep over the 20 minute sessions (both control and music therapy)
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Control
1 of 2
Music Therapy
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: Music Therapy · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 1 - 1 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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:CD013217. doi: 10.1002/14651858.CD013217.pub2.
- 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.
- 2018. "The Effect of Music Therapy on Newborns". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03987165.
Frequently Asked Questions
What criteria must a person meet to be included in this clinical trial?
"This medical investigation is enrolling 300 infants aged 1 minute to one month with passive addiction. In order to participate, they must have been admitted in a NICU or newborn nursery, have a corrected gestational age of 34 weeks or more, not suffer from any hearing disorders, no diagnosed developmental disability (such as Down Syndrome) and their parent/legal guardian must be willing to consent and complete surveys." - Anonymous Online Contributor
Does this experiment currently accept new participants?
"Affirmative. According to clinicaltrials.gov, this medical investigation commenced on December 10th 2018 and is currently recruiting participants. 300 individuals must be enrolled from a single site of the study." - Anonymous Online Contributor
What is the current enrollment capacity for this clinical investigation?
"Affirmative. According to clinicaltrials.gov, the trial that was initially posted on December 10th 2018 is still recruiting volunteers. 300 prospective participants are needed from a single medical site for this experiment." - Anonymous Online Contributor
Are individuals over 45 years of age eligible to participate in this research?
"This trial is including individuals between 1 year and 1 month old." - Anonymous Online Contributor