Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
Primary Purpose
Preterm Birth, Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Based Intervention
Sham Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Birth focused on measuring Music Based Intervention, Preterm Infant Pain Profile
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
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention
Placebo
Arm Description
Participants in this group will be randomized to receive the intervention.
Participants in this group will be randomized to receive a sham treatment.
Outcomes
Primary Outcome Measures
Premature Infant Pain Profile (PIPP) Score
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.
Central Electroencephalography (EEG) Amplitude
EEG will be recorded in 30-hour sessions. Central amplitude will be reported in microvolts.
Event Related Potential (ERP) Amplitude
ERP will be measured during EEG as a measure of neurodevelopment and reported in microvolts.
Secondary Outcome Measures
Full Information
NCT ID
NCT04286269
First Posted
February 24, 2020
Last Updated
December 5, 2022
Sponsor
University of Minnesota
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT04286269
Brief Title
Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
Official Title
Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Pain
Keywords
Music Based Intervention, Preterm Infant Pain Profile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in this group will be randomized to receive the intervention.
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Participants in this group will be randomized to receive a sham treatment.
Intervention Type
Other
Intervention Name(s)
Music Based Intervention
Intervention Description
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
Intervention Name(s)
Sham Treatment
Intervention Description
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 Measure Information:
Title
Premature Infant Pain Profile (PIPP) Score
Description
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.
Time Frame
6 weeks
Title
Central Electroencephalography (EEG) Amplitude
Description
EEG will be recorded in 30-hour sessions. Central amplitude will be reported in microvolts.
Time Frame
6 weeks
Title
Event Related Potential (ERP) Amplitude
Description
ERP will be measured during EEG as a measure of neurodevelopment and reported in microvolts.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonya Wang
Phone
612-301-1454
Email
sgwang@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raghavendra Rao, MD
Phone
612-626-0644
Email
raghurao@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonya Wang, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Wang, MD
Email
sgwang@umn.edu
12. IPD Sharing Statement
Learn more about this trial
Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
We'll reach out to this number within 24 hrs