TERMINATED

PAL to Improve Oral Feeding for Infants With Chronic Lung Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to investigate the effects of the Pacifier Activated Lullaby (PAL) intervention on the transition to oral feeding for preterm infants with chronic lung disease and respiratory distress syndrome that require non-invasive respiratory support at 34 weeks PMA. This study will utilize a clinical trial design. Participants will be randomized into two groups. One group will receive the PAL intervention, the other group serving as a no contact control. Participants will be matched based on sex, gestational age at birth, and neurologic injury. Infants in the intervention group will receive two PAL sessions a week until successfully transitioned to \<2L of respiratory support and then receive one PAL session within 24 hours of their first oral feeding attempt.

Official Title

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

Quick Facts

Study Start:2022-06-08
Study Completion:2025-04-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05446389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 33 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * All infants born less than 33 weeks PMA
  2. * Infants enrolled prior to 35 weeks PMA
  3. * Medically stable to tolerate minimal levels of auditory stimulation
  4. * Approval from medical staff to begin intervention
  5. * 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)
  1. * Infants participating in other music therapy studies.
  2. * Infants in custody of Children's Division
  3. * Requiring non-invasive respiratory support that does not inhibit the start of oral feeding, including High Flow Nasal Cannula (≤ 2L), Nasal Cannula
  4. * Requiring no respiratory support
  5. * Requiring invasive respiratory support
  6. * Infants who are diagnosed with congenital malformations of bowel or bowel perforations
  7. * Infants diagnosed with surgical necrotizing enterocolitis

Contacts and Locations

Study Locations (Sites)

University of Missouri Healthcare
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-08
Study Completion Date2025-04-24

Study Record Updates

Study Start Date2022-06-08
Study Completion Date2025-04-24

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Lung Disease of Prematurity
  • Respiratory Distress Syndrome in Premature Infant
  • Bronchopulmonary Dysplasia
  • Preterm Birth