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

Trial Summary

What is the purpose of this trial?

The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.

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 data supports the effectiveness of the treatment Music Therapy for Premature Infants?

Research shows that music therapy can help improve bonding between mothers and their premature infants, reduce parental anxiety, and support developmental milestones in hospitalized infants. Additionally, music therapy has been found to have positive physiological effects on preterm newborns in the neonatal intensive care unit. ^{1 2 3 4 5}

Is music therapy safe for premature infants?

Research shows that music therapy, including live and recorded music, is generally safe for premature infants in neonatal intensive care units. Studies have not reported any significant safety concerns, but they emphasize the need for standardized protocols to ensure appropriate sound levels and presentation methods. ^{3 6 7 8 9}

How does music therapy differ from other treatments for premature infants?

Music therapy for premature infants is unique because it uses music and parent voices to create a nurturing auditory environment, which can support brain development and sensory processing. Unlike other treatments, it involves personalized, gentle singing that adapts to the infant's needs and includes parents in the therapy process, potentially enhancing the infant's neurodevelopment and parent-infant bonding. ^{6 9 10 11 12}

Eligibility Criteria

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

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

Infants who are medically stable per the clinical care team

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. Norway pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of protocolised music therapy demonstrates developmental milestone acquisition in hospitalised infants. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Music therapy and musical stimulation in the context of prematurity: A narrative literature review from 2010-2015. [2018]

4. Norway pubmed.ncbi.nlm.nih.gov

Music therapy for preterm neonates in the neonatal intensive care unit: An overview of systematic reviews. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

Physiological responses of preterm newborn infants submitted to classical music therapy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of standardized acoustic stimulation in premature infants: a randomized controlled trial. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Live music is beneficial to preterm infants in the neonatal intensive care unit environment. [2014]

9. England pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

Music From the Very Beginning-A Neuroscience-Based Framework for Music as Therapy for Preterm Infants and Their Parents. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Constructing optimal experience for the hospitalized newborn through neuro-based music therapy. [2020]