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Behavioral Intervention

Music Therapy for Prematurity

N/A

Recruiting

Led By Lauren Fagan, MT-BC, LCAT

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newborns born at 24-37 weeks' gestation at Mount Sinai hospital

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study Summary

This trial is testing whether an intervention of six sessions of live ocean disc instrument intervention, given over two weeks, can reduce apnea in premature infants.

Who is the study for?

This trial is for preterm infants born at 24-37 weeks' gestation, considered appropriate for music therapy, and without genetic disorders or hearing issues. It's not suitable for extremely fragile infants unlikely to survive 24 hours or those of uncertain viability.Check my eligibility

What is being tested?

The study tests the effects of ocean disc music therapy on respiratory stability and brain oxygen levels in premature babies. Infants are randomly assigned to receive either this intervention or no sound, with sessions three times a week over two weeks.See study design

What are the potential side effects?

Since the intervention involves gentle ocean sounds played at safe volume levels (40-65dB), side effects are minimal but may include overstimulation if volumes exceed recommended levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn was born prematurely between 24-37 weeks at Mount Sinai.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cerebral oxygen saturation

Heart Rate

Oxygen-Saturation Level

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Participants in this group will receive the ocean disc music therapy entrainment intervention

Group II: Control groupActive Control1 Intervention

Participants in this group will not receive any intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

525,158 Total Patients Enrolled

Joanne V Loewy, DA, MT-BC, LCATStudy DirectorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

272 Total Patients Enrolled

Lauren Fagan, MT-BC, LCATPrincipal InvestigatorMount Sinai Beth Israel

Media Library

Music Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05223192 — N/A

Premature Infants Research Study Groups: Intervention group, Control group

Premature Infants Clinical Trial 2023: Music Therapy Highlights & Side Effects. Trial Name: NCT05223192 — N/A

Music Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05223192 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an estimate of the size of this clinical research program?

"Affirmative, clinicaltrials.gov reveals that this research initiative is actively searching for participants. The study was originally launched on April 15th 2021 and edited most recently as of September 12th 2022. Recruitment efforts are targeting 118 individuals from 1 medical site."

Answered by AI

Who is eligible for enrollment in this clinical trial?

"This clinical trial requires 118 neonates between 24 and 37 weeks' gestation that were born at Mount Sinai hospital. Additionally, only those candidates deemed suitable for clinically indicated music therapy will be admitted to the study."

Answered by AI

Is this study recruiting participants at present?

"Yes, the information hosted on clinicaltrials.gov confirms that this examination is actively recruiting patients at present. It was initially posted April 15th 2022 and most recently updated September 12th 2022; they need to recruit 118 individuals from one centre."

Answered by AI

Is this experimental research open to geriatric individuals?

"This research trial seeks participants who are between 24 and 37 weeks old. Clinicialtrials.gov boasts 199 studies for individuals under 18 years of age and 79 trials for those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants

Joanne Loewy 2022. "The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05223192.

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