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PAL to Improve Oral Feeding for Infants With Chronic Lung Disease

NCT05446389 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-12-09

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Pacifier Activated Lullaby ®

Pacifier Activated Lullaby (PAL®) is a medical device that encourages and reinforces the development of non-nutritive sucking (NNS) of premature infants. This is accomplished by giving positive feedback in the form of music/mother's voice as an auditory input in direct response to effective sucking.

Sponsors & Collaborators

  • University of Georgia

    collaborator OTHER

  • University of Missouri-Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2025-04-24
Completion
2025-04-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05446389 on ClinicalTrials.gov