Preterm BirthNCT04286269
Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
A study testing Music Based Intervention in people with Preterm Birth and Pain, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Pain
- What is being tested?
- Music Based Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infant born at 30 weeks (+/- 2 weeks)
- Medically stable
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neurodevelopment in preterm infants.
Read the 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.
- Conditions
- Preterm Birth, Pain
- Being tested
- Music Based Intervention, Sham Treatment
- Keywords
- Music Based Intervention, Preterm Infant Pain Profile
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Based InterventionOther
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 TreatmentOther
Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this group will be randomized to receive the intervention. Receives: Other: Music Based Intervention |
| Placebo | Sham comparator | Participants in this group will be randomized to receive a sham treatment. Receives: Other: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start20 Nov 2020
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: Due to Covid constraints on recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Sonya Wang, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286269
- Sponsor's protocol ID
- NEUR-2019-27528
- Other IDs
- 1R61AT010712-01
- Status last verified
- Apr 2025
- First submitted
- 24 Feb 2020
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Based Intervention (MBI) on Pain Response and Neurodevelopment in Preterm Infants
- ClinicalTrials.gov ID
- NCT04286269
- Acronym / sponsor ID
- NEUR-2019-27528
- Conditions
- Preterm Birth, Pain
- Keywords
- Music Based Intervention, Preterm Infant Pain Profile
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid constraints on recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Music Based InterventionParticipants in this group will be randomized to receive the intervention. |
| Placebo | Sham comparator | Other: Sham TreatmentParticipants in this group will be randomized to receive a sham treatment. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infant born at 30 weeks (+/- 2 weeks)
- Medically stable
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Based InterventionParticipants 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. | Other | Intervention |
| Sham TreatmentParticipants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones. | Other | Placebo |
Primary outcome
Premature Infant Pain Profile (PIPP) Score
Time frame: 2 weeks
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.
Premature Infant Pain Profile (PIPP) Score
Time frame: 4 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonya Wang, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Based Intervention in people with Preterm Birth and Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Infant Pain Profile (PIPP) Score (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.