Music Therapy for Premature Infants

Recruiting at 1 trial location

Overseen By Yvonne Sheldon, RN, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Genetic anomalies, Severe brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

243 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether music and parent voices can help very premature infants manage stress and improve brain and language development. There are three groups: one listens to standard hospital sounds, another to soothing music (music therapy), and the third to music combined with their parent's voice. The researchers aim to determine if music or a parent's voice helps infants relax and develop better brain connections. Babies born very early (between 24 and 30 weeks) who are stable in the NICU may be suitable for this study. As an unphased trial, this study offers parents a unique opportunity to contribute to innovative research that could enhance early development in premature infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that music therapy is safe for premature infants?

Research shows that music therapy is generally safe for premature babies. Studies have found that music can improve their oxygen levels and breathing, indicating safety. Parents also appreciate it, suggesting it doesn't cause problems.

For treatments using both music and a parent's voice, studies suggest these are also safe and well-received by parents. While they might not significantly impact language development compared to regular care, they cause no harm.

Overall, both music therapy alone and with a parent's voice are well-tolerated by premature babies, with no serious safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using music therapy for premature infants because it offers a gentle, non-invasive approach to soothing and supporting their development. Unlike the standard care, which often involves exposure to ambient NICU noise, this treatment involves playing calming music or lullabies via infant-adapted headphones, creating a more relaxing environment. The "Music and parent voice" option is particularly unique because it incorporates the comforting sound of a parent's voice, potentially enhancing the calming effect and strengthening the parent-infant bond. This innovative approach not only aims to reduce stress for these vulnerable infants but also invites parents to actively participate in their care, which could have lasting emotional benefits.

What evidence suggests that this trial's music therapy treatments could be effective for premature infants?

Research has shown that music therapy, one of the treatments in this trial, can benefit premature babies by slowing their heart rates, improving their breathing, and reducing pain. Music activities also correlate with better brain development and less stress in these babies. Another treatment arm in this trial combines music therapy with a parent's voice. Studies suggest that a parent's voice can capture a baby's attention and aid in developing vocal skills. When parents sing, it may increase brain activity, making this combination a promising way to support premature babies. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for very preterm infants to explore how music and parent voice can affect their brain development and behavior. Infants must be born prematurely and will be observed until they are two years old. Specific details on inclusion or exclusion criteria were not provided.

Inclusion Criteria

Infants who are medically stable per the clinical care team

My baby was born very early, between 24 and 31 weeks of pregnancy, at a specific hospital.

Exclusion Criteria

My infant has a genetic condition linked to developmental delays.

My parents are not able to fill out forms in English or Spanish.

My infant has a severe brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

NICU Hospitalization

Very preterm infants are hospitalized in the NICU for intensive medical care and developmental interventions

2-4 months

Continuous care in NICU

Music-Based Intervention (MBI)

Music therapy with or without parental voice is administered to reduce stress and enhance neurodevelopment

Until term-equivalent age (37-41 weeks PMA)

Regular sessions post-care and feeding times

Follow-up

Participants are monitored for neurodevelopmental outcomes and physiological measures

Up to 2 years corrected age

Periodic assessments including Bayley-4 and MRI

What Are the Treatments Tested in This Trial?

Interventions

• Music
• Music and parent voice

Trial Overview

The study tests the effects of music alone (M) or combined with a parent's voice (MPV) versus standard care on stress levels, brain development, and language outcomes in premature infants. It's a randomized control trial conducted at two sites.

How Is the Trial Designed?

Group I: Music and parent voice Experimental Treatment 1 Intervention

The selected lullabies will be pre-recorded by the MT as described above to include a guitar accompaniment track, and a separate vocal track with the MT singing along, in two separate keys to allow variation for parent voice range and comfort. Parents will be invited to sing along with the recorded track of MT singing, and MT will later remove the MT-voice recording track so only the parent voice will be heard with the guitar in the final recording. Timing: MBI to be administered after regular NICU "care and feeding" times, which are typically considered stressful times for infants. The goal of the intervention will be to provide a calming and relaxing experience to the infant as they "settle" back to sleep after handling times. Music delivery will occur via infant-adapted headphones to facilitate blinding.

Group II: Music Experimental Treatment 1 Intervention

We will create three recordings with increasing complexity for each infant. For each infant developmental stage (32, 34, 36+ weeks PMA), Music Therapists (MTs) in both units will present parents with a curated list of 8-10 musically comparable, familiar lullabies to select from. Songs will be available in different languages reflective of patient diversity, with rhythm, tempo, pitch range/ change, instrumentation, melody, harmony selected drawing on available evidence, including BWH NICU pilot data. Timing: MBI to be administered after regular NICU "care and feeding" times, which are typically considered stressful times for infants. The goal of the intervention will be to provide a calming and relaxing experience to the infant as they "settle" back to sleep after handling times. Music delivery will occur via infant-adapted headphones to facilitate blinding.

Group III: Reference/ Standard of care Active Control 1 Intervention

These are infants recruited in the study who will receive the unit standard of care. They will be listening to the NICU ambient noise via infant-adapted headphones but will not receive any music intervention.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Yale New Haven Health System Center for Healthcare Solutions

Collaborator

Trials

6

Recruited

5,600+

Published Research Related to This Trial

Premature infants experience unique challenges in sensory processing development, which can lead to sensory processing disorders.

Music therapy, when tailored to the developmental needs of premature infants, can be an effective intervention in the NICU, potentially reducing the risks of sensory processing disorders when combined with nursing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Sensory Processing in Premature Infants and Implications for Evidence-Based Music Therapy in the NICU. Pivovarnik, ES.[2022]

A review of 20 studies on the effects of music on premature and full-term infants revealed a lack of standardized protocols for presenting musical stimuli, highlighting the need for consistency in future research.

The study suggests several areas for further investigation, including the appropriate gestational age for music therapy, optimal decibel levels for infant safety and effectiveness, and the impact of different presentation methods on sound delivery to infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presentation of Aural Stimuli to Newborns and Premature Infants: An Audiological Perspective. Cassidy, JW.[2019]

A meta-analysis of music research involving premature infants in NICUs revealed a significant positive effect of music on their health, with an effect size of d = 0.83, indicating substantial benefits.

The study found that the benefits of music were consistent regardless of factors like gestational age, birthweight, or type of music delivery, suggesting that music therapy could be a valuable intervention for improving outcomes in premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the efficacy of music therapy for premature infants. Standley, JM.[2022]

A study involving 213 families of premature infants evaluated the effects of music therapy on mother-infant bonding, parental anxiety, and maternal depression, but found no significant differences between the music therapy group and the standard care group at discharge.

Despite the music therapy sessions being well-received, with 98% of participants completing the treatment, the results indicated that parent-led singing did not improve bonding or reduce anxiety and depression among parents compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. Gaden, TS., Ghetti, C., Kvestad, I., et al.[2022]

In a study involving 12 preterm newborns, music therapy sessions led to a significant decrease in heart rate after the second session and an increase in oxygen saturation after the fifth session, indicating potential benefits for physiological stability.

The results suggest that music therapy can positively influence short-term physiological responses in hospitalized preterm infants, which may aid in their overall care and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological responses of preterm newborn infants submitted to classical music therapy. da Silva, CM., Cação, JM., Silva, KC., et al.[2019]

Music therapy (MT) for preterm infants in the neonatal intensive care unit (NICU) has shown to significantly reduce heart rate and respiratory rate, and decrease maternal anxiety, based on a meta-analysis of 14 randomized trials.

While MT appears to improve short-term physiological parameters and feeding volume, the evidence is of low to very low certainty, and there are no reported long-term safety or neurodevelopmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for preterm neonates in the neonatal intensive care unit: An overview of systematic reviews. Mohan, A., Gokulakrishnan, G., El-Saie, A., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6863102/

Musical and vocal interventions to improve ...

We will assess the overall efficacy of auditory stimulation for physiological and neurodevelopmental outcomes in preterm infants (< 37 weeks' gestation), ...

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2818754

Music Therapy in Infancy and Neurodevelopmental ...

Meta-analyses have shown beneficial short-term effects of music therapy (MT) on infant heart rate, respiratory rate, oral feeding volume, and ...

3.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0316674

A systematic review and dose-response meta-analysis

In our meta-analysis, we found that music therapy had a statistically significant effect on reducing pain and improving the behavioral state of premature ...

4.

nature.com

nature.com/articles/s41390-024-03329-7

The effect of early postnatal auditory stimulation on ...

The meta-analysis demonstrated that, overall, music interventions are effective in reducing Premature Infant Pain Profile scores and stress ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667009725000296

Family music therapy combined with oral motor ...

Recorded musical elements and sound stimulation are played to preterm infants to enhance brain development. Music therapy can promote the growth and development ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3826794/

Music Therapy in the NICU: Is there Evidence to support ...

The results showed that in the 10-minutes following the music intervention, the previously agitated infant had statistically significantly improved oxygen ...

7.

publications.aap.org

publications.aap.org/pediatrics/article/149/2/e2021052797/184394/Short-term-Music-Therapy-for-Families-With-Preterm

Short-term Music Therapy for Families With Preterm Infants

Significant positive effects of music therapy (MT) have been confirmed on premature infants' respiratory rate and maternal anxiety. Small-scale ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06844396?utm_source=trialradar

The Impact of NICU Music Therapy for Preterm Infants and ...

The study will also gather data relating to feeding behaviours, weight gain, length of stay and sleep patterns as well as follow up data relating to ...