Status:
TERMINATED
Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Preterm Birth
Pain
Eligibility:
All Genders
28-32 years
Phase:
NA
Brief Summary
Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neurodevelopment in preterm infants.
Detailed Description
Aim 1: Premature infant pain profiles (PIPP) include physiologic, behavioral, and contextual measures which identifies differences in pain responses between music-based intervention (MBI) and controls...
Eligibility Criteria
Inclusion
- Preterm infant born at 30 weeks (+/- 2 weeks)
- Medically stable
Exclusion
- Treatment for major organ system disease
- Significant neurological disorder including, but not limited to, abnormal neurological examination, neonatal abstinence syndrome, intraventricular hemorrhage, seizures, meningitis, or congenital brain malformations
- Scalp lesions affecting EEG placement
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04286269
Start Date
November 20 2020
End Date
October 1 2023
Last Update
April 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455