Music Intervention for Premature Birth

Recruiting at 2 trial locations

Overseen By Joanne V Loewy

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: All except prenatal vitamins

Disqualifiers: Non-pregnant, Chronic conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

142 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.

Will I have to stop taking my current medications?

Yes, participants must not be regularly taking any medications other than prenatal vitamins to be eligible for the trial.

What data supports the effectiveness of the treatment Music Intervention for premature birth?

Research shows that music therapy has significant benefits for premature infants in neonatal intensive care units, improving their physiological, behavioral, and developmental outcomes. This suggests that music intervention can be an effective treatment for premature infants. ^{1 2 3 4 5}

Is music intervention safe for use in humans?

Research on psychosocial treatments, which can include music interventions, shows that serious adverse events are rare and not typically related to the study itself. This suggests that music interventions are generally safe for human use. ^{6 7 8 9 10}

How does the Music Intervention for Premature Birth treatment differ from other treatments for premature infants?

The Music Intervention for Premature Birth treatment is unique because it combines music therapy with verbal intervention to aid in the feeding progression of premature infants, potentially reducing their hospital stay. Unlike standard treatments, this approach uses music to create a calming environment, which can help stabilize vital signs and improve feeding readiness in preterm infants. ^{1 2 11 12 13}

Research Team

Joanne V. Loewy, DA, LCAT, MT-BC

Principal Investigator

Icahn School of Medicine at Mount Sinai

Elizabeth J. Corwin, PhD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for healthy pregnant Black women aged 18 to 40 in their first trimester. It's not for those who aren't pregnant, have chronic health issues affecting pregnancy, or take regular medication (other than prenatal vitamins).

Inclusion Criteria

I am between 18 and 40 years old.

I am a healthy pregnant woman in my first trimester.

Exclusion Criteria

I am not pregnant.

I have a chronic condition that could affect a pregnancy.

I am a woman taking medication other than prenatal vitamins regularly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a culturally-based live music intervention or a sham control verbal intervention to assess the impact on stress and preterm birth outcomes

10 weeks

Weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of gestational age and stress levels

Up to 43 weeks

Treatment Details

Interventions

• Music Intervention
• Verbal Intervention

Trial Overview The study compares a music intervention (MI) with a sham control (SC), which involves only talking. The goal is to see if MI can lessen the stress effects on pregnant women, reduce premature births, and boost infant health.

Participant Groups

Group I: Music Intervention (MI) Group Experimental Treatment 1 Intervention

Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.

Group II: Sham Control (SC) Group Active Control 1 Intervention

Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only).

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Findings from Research

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]

In a study involving 40 preterm infants born before 32 weeks' gestation, live music therapy significantly improved vital signs, such as heart rate and oxygen saturation, regardless of whether physical contact was made during the sessions.

While physical contact during music therapy led to better baseline and post-therapy vital sign values, it did not enhance the overall response to the therapy, indicating that the benefits of music therapy for preterm infants are independent of physical touch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Physical Contact on Preterm Infants' Vital Sign Response to Live Music Therapy. Kobus, S., Diezel, M., Dewan, MV., et al.[2023]

Music therapy for preterm infants in the neonatal intensive care unit (NICU) shows a large significant effect size (Cohen's d = 0.82), indicating it is highly beneficial for their development and medical outcomes.

Live music therapy, especially when implemented early in the NICU stay for infants with very low birth weight (under 1,000 g) or extremely preterm (under 28 weeks), provides the greatest benefits, supporting its inclusion in best practice standards for NICU treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy research in the NICU: an updated meta-analysis. Standley, J.[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]

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]

A review of pediatric psychopharmacology trials over the past 10 years revealed that only 11.8% utilized a data and safety monitoring board (DSMB), indicating a significant gap in safety monitoring practices for this vulnerable population.

Most trials relied on basic safety elicitation methods, such as laboratory tests and vital signs, with only 6% depending solely on spontaneous reporting of adverse events, highlighting the need for improved safety protocols in pediatric research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. Yuill, K., Carandang, C.[2013]

Transcatheter PDA occlusion in infants under 6 kg has a high procedural success rate of 94.3%, but major adverse events (MAEs) occurred in 12.6% of cases, with acute arterial injury and device embolization being the most common complications.

Younger infants (under 30 days) and those weighing less than 2 kg are at a significantly higher risk for MAEs, indicating that careful patient selection is crucial for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Occlusion of the Patent Ductus Arteriosus in 747 Infants Backes, CH., Kennedy, KF., Locke, M., et al.[2019]

In a study analyzing pediatric hospitalizations, 24 patients experienced 29 adverse events (AEs) related to medical care, with a rate of 3.61% across all pediatric hospitalizations, which is lower than the 6.4% rate seen in non-elderly adults.

A significant 65.5% of these adverse events were deemed preventable, highlighting the need for targeted prevention strategies, especially since medication-related events accounted for 37.9% of the incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. Requena, J., Miralles, JJ., Mollar, J., et al.[2012]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

A study of 1,977 suspected Serious Adverse Drug Reactions (SADRs) in Brazilian children revealed that nearly 30% of these cases involved infants aged 0-1 year, highlighting the vulnerability of this age group to medication-related harms.

The analysis identified 107 signals of disproportionate reporting (SDRs), with 15% of these events not listed on product labels, indicating a need for further investigation into specific drug-event pairs and the safety of intravenous medications and off-label drug use in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study. Vieira, JML., de Matos, GC., da Silva, FAB., et al.[2020]

Premature infants receiving a combination of oral motor intervention and music therapy achieved independent oral feeding 8 days earlier than those who only received oral motor intervention, indicating a significant improvement in feeding progression.

The intervention group also showed a greater mean volume of milk intake on the 10th day and a higher score on the Preterm Oral Feeding Readiness Scale, suggesting that combining these therapies can enhance feeding outcomes and potentially reduce NICU stay, although weight gain was similar between both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of premature infant oral motor intervention [PIOMI] combined with music therapy on feeding progression of preterm infants: a randomized control trial. Shokri, E., Zarifian, T., Soleimani, F., et al.[2023]

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 review of 22 pediatric studies on music-based interventions highlighted significant gaps in how these interventions are reported, particularly in areas like music qualities and intervention delivery methods.

The findings suggest a need for standardized reporting guidelines to enhance the clarity and effectiveness of music-based interventions in research and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of music-based intervention reporting in pediatrics. Robb, SL., Carpenter, JS.[2022]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Physical Contact on Preterm Infants' Vital Sign Response to Live Music Therapy. [2023]

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

Music therapy research in the NICU: an updated meta-analysis. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

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

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

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

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

Safety methodology in pediatric psychopharmacology trials. [2013]

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

Transcatheter Occlusion of the Patent Ductus Arteriosus in 747 Infants [2019]

8. Spain pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. [2012]

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

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study. [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

Effect of premature infant oral motor intervention [PIOMI] combined with music therapy on feeding progression of preterm infants: a randomized control trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

A review of music-based intervention reporting in pediatrics. [2022]