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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286269
• Other study ID #: NEUR-2019-27528
• Secondary ID: 1R61AT010712-01
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neurodevelopment in preterm infants.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Premature Birth
• Preterm Birth

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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	Central Electroencephalography (EEG) Amplitude	EEG will be recorded in 30-hour sessions. Central amplitude will be reported in microvolts.	6 weeks
Primary	Event Related Potential (ERP) Amplitude	ERP will be measured during EEG as a measure of neurodevelopment and reported in microvolts.	6 weeks