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Search / Trial NCT05446389

PAL to Improve Oral Feeding for Infants With Chronic Lung Disease

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Jun 30, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Music Therapy Nicu Pacifier Activated Lullaby Premature Infant Chronic Lung Disease Oral Feeding

ClinConnect Summary

This clinical trial, called the PAL study, is examining how a special program using music and sound, known as the Pacifier Activated Lullaby (PAL), can help preterm infants with chronic lung disease and breathing issues start eating by mouth. The study focuses on infants born before 33 weeks of pregnancy who are receiving certain types of breathing support that make it harder for them to begin oral feeding. If your baby is eligible, they may be enrolled in one of two groups: one will receive the PAL music sessions twice a week, while the other group will not receive any intervention.

To be considered for this study, your baby should be medically stable and able to handle some gentle sounds. It's important to note that babies who are currently part of other music therapy studies or have certain medical conditions will not be eligible. If your baby participates, you can expect them to receive PAL sessions until they are ready to decrease their breathing support and try eating by mouth. This research hopes to find new ways to help babies transition to oral feeding more effectively.

Gender

ALL

Eligibility 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

About University Of Missouri Columbia

The University of Missouri-Columbia is a leading academic institution dedicated to advancing medical research and clinical innovation. As a prominent sponsor of clinical trials, the university leverages its extensive resources and expertise to facilitate groundbreaking studies aimed at improving patient outcomes across a variety of health conditions. With a commitment to ethical research practices and collaboration with multidisciplinary teams, the University of Missouri-Columbia strives to translate scientific discoveries into effective therapeutic interventions, ultimately enhancing the quality of care in the communities it serves.

Locations

Columbia, Missouri, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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