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

NCT04286269 | Terminated Results DMC

• 2 other identifiers: NEUR-2019-275281R61AT010712-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Pain

Keywords

Music Based Intervention; Preterm Infant Pain Profile

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks

• 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.

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Music Based Intervention

Placebo

SHAM COMPARATOR

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

Other: Sham Treatment

Interventions

Music Based Intervention OTHER

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

Sham Treatment OTHER

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

Placebo

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infant born at 30 weeks (+/- 2 weeks)
• Medically stable

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Premature Birth; Pain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sonya Wang
• Organization: University of Minnesota

sgwang@umn.edu

612-301-1454

Study Officials

• Sonya Wang, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: November 20, 2020
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 23, 2025
• Results First Posted: April 23, 2025

Record last verified: 2025-04

Locations

US (1)