We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04286269
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : December 6, 2022
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Preterm Birth Pain Other: Music Based Intervention Other: Sham Treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinding will be maintained by using identical headphones and MP3 players for all subjects. The PI, any personnel involved in collecting the clinical outcomes (e.g., PIPP) or collecting or quantifying EEG outcomes, and the statistician will be blinded.
Primary Purpose: Treatment
Official Title: Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Arm Intervention/treatment
Experimental: Intervention
Participants in this group will be randomized to receive the intervention.
Other: 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.

Sham Comparator: Placebo
Participants in this group will be randomized to receive a sham treatment.
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.

Primary Outcome Measures :
  1. Premature Infant Pain Profile (PIPP) Score [ Time Frame: 6 weeks ]
    The Premature Infant Pain Profile (PIPP) is a pain scoring system assessing 7 indicators: observed change in heart rate, observed decrease in percent oxygen saturation; observed facial expressions of pain (brow bulge, eye squeeze, and naso-labial furrow); gestational age; and behavioral state. Clinicians rate each indicator on a scale from 0 to 3 using a set scoring system. Total scores range 0 to 21, with higher scores indicating greater pain.

  2. Central Electroencephalography (EEG) Amplitude [ Time Frame: 6 weeks ]
    EEG will be recorded in 30-hour sessions. Central amplitude will be reported in microvolts.

  3. Event Related Potential (ERP) Amplitude [ Time Frame: 6 weeks ]
    ERP will be measured during EEG as a measure of neurodevelopment and reported in microvolts.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   28 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04286269

Layout table for location contacts
Contact: Sonya Wang 612-301-1454 sgwang@umn.edu
Contact: Raghavendra Rao, MD 612-626-0644 raghurao@umn.edu

Layout table for location information
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sonya Wang, MD       sgwang@umn.edu   
Sponsors and Collaborators
University of Minnesota
National Center for Complementary and Integrative Health (NCCIH)
Layout table for investigator information
Principal Investigator: Sonya Wang, MD University of Minnesota
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04286269    
Other Study ID Numbers: NEUR-2019-27528
1R61AT010712-01 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: December 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Music Based Intervention
Preterm Infant Pain Profile
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases