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NCT05446389 · ClinicalTrials.gov registry record · NA
PAL to Improve Oral Feeding for Infants With Chronic Lung Disease
A NA study, sponsored by University of Missouri-Columbia.
- Terminated
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT05446389: Clinical Trial NA study, sponsored by University of Missouri-Columbia.
NCT05446389 is a NA study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05446389, a NA study, was terminated before completion, sponsored by University of Missouri-Columbia.
- TERMINATED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
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.
Primary Outcome
Time to full transition from gavage to oral feeding by mouth as measured by days
Interventions
- DEVICE Pacifier Activated Lullaby ®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-06-08 |
| Est. Completion | 2025-04-24 |
| Phase | NA |
Why NCT05446389 stopped before completion
NCT05446389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Pacifier Activated Lullaby ® is the first listed.
NCT05446389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05446389 about?
NCT05446389 is a clinical study titled "PAL to Improve Oral Feeding for Infants With Chronic Lung Disease". 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 wil...
What is the current status of trial NCT05446389?
This trial is currently terminated. It is a NA study. The enrollment target is 33 participants. The study started on 2022-06-08. Estimated completion is 2025-04-24.
What interventions are being tested in trial NCT05446389?
The interventions under investigation include: Pacifier Activated Lullaby ® (DEVICE).
Who is sponsoring clinical trial NCT05446389?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05446389's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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