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

University of Minnesota (UMN)

Status: Terminated

Conditions: Pain; Preterm Birth

Treatments: Other: Music Based Intervention; Other: Sham Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04286269

NEUR-2019-27528

1R61AT010712-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 28 to 32 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: Music Based Intervention

Placebo

Sham Comparator group

Description:

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

Treatment:

Other: Sham Treatment