Musical pacifier may help preemies with lung disease eat sooner
NCT ID NCT05446389
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a special pacifier that plays music or a mother's voice when a baby sucks correctly. It aimed to help premature infants with chronic lung disease learn to feed by mouth more quickly. The trial enrolled 33 babies but was stopped early, so the results are not conclusive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pacifier Activated Lullaby (PAL) device
- What this could lead to
- If it works, this device could help premature babies with lung problems learn to feed by mouth faster, reducing their time in the NICU.
- What could go wrong
- The trial was terminated early with only 33 participants, so results are limited. It is unclear if the device provides meaningful benefits over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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33 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day to 33 weeks
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Missouri Healthcare
Columbia, Missouri, 65212, United States
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Other studies related to the condition(s) this trial covers.
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