Clinical trial NCT04286269: 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
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Birth
Pain
Keywords: Music Based Intervention
Preterm Infant Pain Profile
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-02-26
Enrollment: 28
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Premature Infant Pain Profile (PIPP) Score
timeFrame: 2 weeks
measure: Premature Infant Pain Profile (PIPP) Score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sonya Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: