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Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neurodevelopment in preterm infants.
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
University of Minnesota
Minneapolis, Minnesota, United States
Start Date
November 20, 2020
Primary Completion Date
October 1, 2023
Completion Date
October 1, 2023
Last Updated
April 23, 2025
28
ACTUAL participants
Music Based Intervention
OTHER
Sham Treatment
OTHER
Lead Sponsor
University of Minnesota
Collaborators
NCT06346132
NCT07482709
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07351968