RECRUITING

PAL to Improve Oral Feeding for Infants With Chronic Lung Disease

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.

Study Overview

Study Details

Study overview

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.

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

PAL to Improve Oral Feeding for Infants With Chronic Lung Disease

Condition
Chronic Lung Disease of Prematurity
Intervention / Treatment

-

Contacts and Locations

Columbia

University of Missouri Healthcare, Columbia, Missouri, United States, 65212

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

1 Day to 33 Weeks

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Missouri-Columbia,

Study Record Dates

2026-12-31