CLINICAL TRIAL

Music Based Intervention for Premature Birth

Recruiting · < 18 · All Sexes · Minneapolis, MN

This study is evaluating whether music may help reduce pain in premature infants.

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About the trial for Premature Birth

Eligible Conditions
Premature Birth · Pain · Premature Births

Treatment Groups

This trial involves 2 different treatments. Music Based Intervention is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Music Based Intervention
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sham Treatment
OTHER

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Preterm infant born at 30 weeks (+/- 2 weeks)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Music Based Intervention will improve 3 primary outcomes in patients with Premature Birth. Measurement will happen over the course of 6 weeks.

Central Electroencephalography (EEG) Amplitude
6 WEEKS
EEG will be recorded in 30-hour sessions. Central amplitude will be reported in microvolts.
Premature Infant Pain Profile (PIPP) Score
6 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.
Event Related Potential (ERP) Amplitude
6 WEEKS
ERP will be measured during EEG as a measure of neurodevelopment and reported in microvolts.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has music based intervention proven to be more effective than a placebo?

Music based intervention was highly effective in reducing preterm birth rates. There is currently not much music based intervention research, however, some of it has been done. Most research in this area is inconclusive and further study is necessary.

Anonymous Patient Answer

How many people get premature birth a year in the United States?

There is an increasing interest and implementation of new screening and prevention programs for prematurity in the United States. While the data are still limited, the overall prevalence of premature births has declined over the past few years. This reduction might be partially attributed to increasing prenatal care and improved neonatal care. However, the overall rate of premature births remains at 8-9% for most geographic areas.

Anonymous Patient Answer

Can premature birth be cured?

Premature birth is not a disease. Unless there have been severe and long-lasting effects, children with severe premature birth can survive. The majority of children with premature birth have few symptoms, and most have little disability. As these children grow up, most are fully integrated into their family or community by their teenage years.

Anonymous Patient Answer

What are the signs of premature birth?

Many neonates remain in the neonatal intensive care unit for the first week after birth. It is very important that neonates receive the optimum care in this critical period and these signs should be taken into account. Severe signs include low blood flow or a rapid pulse. Other indications of premature birth include blue skin due to an insufficient amount of oxygen available, and an excessively low birth weight.

Anonymous Patient Answer

What causes premature birth?

Although there are several possible risk factors, no single risk factor explains the full spectrum of premature birth. Preventing premature birth is a health strategy that will be an important component of public health programs to reduce premature birth rates in developed regions. Public health prevention strategies should target women at risk for premature birth and promote healthy childbearing while reducing the risk of developing diabetes.

Anonymous Patient Answer

What is premature birth?

Premature birth refers to births that occur before 37 weeks of gestation. The most common symptoms in mothers and neonates are respiratory distress and low birth weight. These birth defects are associated with an increased risk of developing heart disease, high blood pressure later in life, diabetes, and cancer. Studies have found that low birth weight can cause significant damage to brain development, and premature birth is a strong predictor of neurological compromise and later illness.

Anonymous Patient Answer

What are common treatments for premature birth?

The authors' data are limited, but one in 10 babies born very low birthweight in Canada will not survive the first two years of life. They have provided important information for clinicians who manage preterm infant populations and offer clinical practice recommendations.

Anonymous Patient Answer

How serious can premature birth be?

At 7-8 months (mean 2.9 and 95% C.I. 2.4-3.0), a low birth weight is one of the strongest risk factors for long-term disability; for a high birth weight, more than 20% of the cases of disability would be prevented if their birth weight were to match that of a term infant.

Anonymous Patient Answer

What is music based intervention?

Musical intervention resulted in significant improvements in early language development, but more research is necessary to better define the optimum type, length, and target group to best affect language development in pre-lingually and premally deaf toddlers.

Anonymous Patient Answer

Does music based intervention improve quality of life for those with premature birth?

The use of music-based interventions to address the concerns of women with a history of preterm birth improves their QoL and can increase the chances of having a live preterm birth. However, there are some concerns about the high drop-out rate for the study group.

Anonymous Patient Answer

Is music based intervention safe for people?

Exposure to moderate music therapy was not associated with adverse outcomes. Patients in the music intervention group were more likely to resume normal activities following treatment and the intervention had little adverse effect on recovery. Music therapy should be evaluated as an intervention for infants and young children after premature birth.

Anonymous Patient Answer

Have there been other clinical trials involving music based intervention?

(1) No research has investigated the efficacy of music, other than a musical instrument, for premature infants. (2) No music based intervention has been shown to be non-inferior to a standard care/standard intervention based on the NICU standard of care.

Anonymous Patient Answer
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