Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants

NCT ID: NCT04286269

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2023-10-01

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 while still in the neonatal intensive care unit (NICU). Central EEG amplitude changes have been time-locked with painful procedures in term infants. We will explore if PIPP scores and central EEG amplitude changes are attenuated with MBI in comparison to controls.

Hypothesis 1: MBI will show improved pain responses, with lower PIPP scores and attenuated central EEG amplitude changes during painful procedures, in comparison to the control cohort.

Aim 2: EEG is a surrogate marker for real time brain function during sleep-wake cycles. Because preterm brain networks develop during sleep, sleep duration is a strong indicator of brain maturation. Serial biweekly EEGs of preterm infants can quantify sleep duration trends and track MBI's influence on sleep. To enhance objectivity, innovative EEG machine-learning tools will be applied to the analyses.

Hypothesis 2: MBI will enhance preterm EEG brain maturation in comparison to controls.

Due to the natural limitations of evaluating immature neonatal nervous systems, ERPs have been utilized to study early neurodevelopment. ERPs quantify electrical brain potentials changes time-locked with a stimulus. Auditory ERPs performed at 1 month corrected age evaluates attention and discrimination between familiar and novel stimuli - early neurodevelopmental signs of recognition memory function and perceptual learning.

Hypothesis 3: ERPs at 1 month corrected age will show that MBI has a greater impact on early neurodevelopment when compared to controls.

Conditions

Preterm Birth; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Participants in this group will be randomized to receive the intervention.

Group Type: EXPERIMENTAL

Music Based Intervention

Intervention Type: OTHER

Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.

Placebo

Participants in this group will be randomized to receive a sham treatment.

Group Type: SHAM_COMPARATOR

Sham Treatment

Intervention Type: OTHER

Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.

Interventions

Music Based Intervention

Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.

Intervention Type: OTHER

Sham Treatment

Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Preterm infant born at 30 weeks (+/- 2 weeks)
• Medically stable

Exclusion Criteria

• 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

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonya Wang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R61AT010712-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NEUR-2019-27528

Identifier Type: -

Identifier Source: org_study_id