Using music therapy to help preterm infants with lung disease feed orally
The Use of the Pacifier Activated Lullaby to Improve the Transition to Oral Feeding for Premature Infants With Chronic Lung Disease or Respiratory Distress Syndrome
This study is testing if music therapy can help preterm infants with lung disease learn to feed by mouth more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Day to 33 Weeks |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT05446389 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of the Pacifier Activated Lullaby (PAL) intervention on the ability of preterm infants with chronic lung disease to transition to oral feeding. Infants requiring non-invasive respiratory support will be randomized into two groups: one receiving PAL sessions and the other serving as a control group with no additional intervention. The PAL sessions will occur twice a week until the infants are on less than 2 liters of respiratory support, followed by a session before their first oral feeding attempt. The study aims to assess whether this music therapy approach can facilitate oral feeding in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born before 33 weeks of gestational age who require non-invasive respiratory support.
Not a fit: Patients who are not on respiratory support or those requiring invasive respiratory support will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve the oral feeding transition for preterm infants with chronic lung disease, potentially enhancing their overall health outcomes.
How similar studies have performed: While music therapy has been explored in various contexts, this specific application of the PAL intervention for preterm infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All infants born less than 33 weeks PMA * Infants enrolled prior to 35 weeks PMA * Medically stable to tolerate minimal levels of auditory stimulation * Approval from medical staff to begin intervention * Requiring non-invasive respiratory support that inhibits the start of oral feeding, including: Continuous Positive Airway Pressure (CPAP), Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA), Non-Invasive Ventilator (NIV), High Flow Nasal Cannula (\>2L), and Non-invasive positive pressure ventilation (NIPPV) Exclusion Criteria: * Infants participating in other music therapy studies. * Infants in custody of Children's Division * Requiring non-invasive respiratory support that does not inhibit the start of oral feeding, including High Flow Nasal Cannula (≤ 2L), Nasal Cannula * Requiring no respiratory support * Requiring invasive respiratory support * Infants who are diagnosed with congenital malformations of bowel or bowel perforations * Infants diagnosed with surgical necrotizing enterocolitis
Where this trial is running
Columbia, Missouri
- University of Missouri Healthcare — Columbia, Missouri, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.