Chronic Lung Disease of PrematurityNCT05446389
PAL to Improve Oral Feeding for Infants With Chronic Lung Disease
A study testing Pacifier Activated Lullaby ® in people with Chronic Lung Disease of Prematurity and Respiratory Distress Syndrome in Premature Infant, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 33 weeks
- Conditions the study is for
- Chronic Lung Disease of Prematurity, Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
- What is being tested?
- Pacifier Activated Lullaby ®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Healthcare
Columbia, Missouri, 65212
About this study
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
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.
Read the detailed description
Infants in the Neonatal Intensive Care Unit at MU Healthcare receive consultations for music therapy services upon admission. The PAL intervention used in this study is a part of routine care that would happen regardless of participation in this study. The Music Therapist will discuss study with the parents of infants who meet inclusion criteria between 32 to 34 weeks PMA.
Clinical all infants on non-invasive respiratory support have a room air trial at 34 weeks PMA. Infants who fail their room air trail and are still on non-invasive respiratory support that is >2L will be randomized to either the control or intervention group. The control group will receive no additional intervention.
The experimental group will begin 2 PAL sessions per gestation week of age such that infants receive two sessions between 34 0/7 and 34 6/7, two sessions between 35 0/7 and 35 6/7, etc. When the infant is on <2L of respiratory support they will receive one more PAL session within 24 hours prior to their first oral feeding attempt.Infants in the experimental group will receive no additional PAL sessions after they begin oral feeding trials. PAL sessions will utilize the Pacifier Activated Lullaby device (PAL®) that is an FDA cleared medical device for use with preterm infants in the NICU. Sessions will be 15 minutes in length and be during the infant's gavage feed.The music therapist will get approval from the bedside RN prior to beginning any PAL sessions.The infant will be prompted with the pacifier by touching the pacifier to the infant's lips. If the infant doesn't accept pacifier in mouth after 3 attempts the music therapy will gently stroke the infant's cheeks to prompt the rooting reflex and then prompt with the pacifier. If the infant doesn't accept the pacifier in their mouth, then the music therapist will stop the session attempt and it will not count as a PAL session. If the infant pauses in non-nutritive sucking (NNS) for more than 30 seconds with music therapist will prompt the infant by moving pacifier in infant's mouth. This will be attempted 3 times if needed. If the infant still doesn't engage in NNS then the music therapy will stroke the infant's cheek and then move pacifier in mouth. This will be done twice. If the infant still does not engage in NNS then the session will be ended. The session will count if it lasted 8 minutes in length prior to the music therapist beginning prompting. If it was less than 8 minutes then it will not count towards a completed PAL session.
- Conditions
- Chronic Lung Disease of Prematurity, Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia, Preterm Birth
- Being tested
- Pacifier Activated Lullaby ®
- Keywords
- Music Therapy, NICU, Pacifier Activated Lullaby, Premature Infant, Chronic Lung Disease, Oral Feeding
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacifier Activated Lullaby ®Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Infants randomized in to the experimental group will receive the PAL intervention 2 times a week until the infant transitions to room air or < 2L high flow nasal cannula and is able to begin attempting feeds by mouth. The PAL is an FDA cleared medical device that has a sensor that will connect to the infant's pacifier and can read the infant's suck. Then, the device plays music as positive reinforcement to help improve sucking skills. This intervention typically lasts about 15 minutes and is implemented while the infant is receiving gavage feeds. Receives: Device: Pacifier Activated Lullaby ® |
| Control Group | No intervention | Infants randomized in to the control group will not receive music therapy intervention throughout NICU admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Feeding
Time to full transition from gavage to oral feeding by mouth as measured by days
Measured: 1-6 weeks
Secondary outcomes (2)
Length of Stay
Length of time admitted in the NICU as measured by days
Measured: 1-8 months
Length of Respiratory Support
Length of time before transition to breathing room air as measured by days
Measured: 1-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start8 Jun 2022
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Why it stopped: PI left the institution \& the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Lung Disease of PrematurityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Georgia
- Responsible party
- Principal investigator, Emily Pivovarnik, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446389
- Sponsor's protocol ID
- 2091032
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We have no plan to make IPD available to other researchers.
Publications
Dumpa V, Kamity R, Ferrara L, Akerman M, Hanna N. The effects of oral feeding while on nasal continuous positive airway pressure (NCPAP) in preterm infants. J Perinatol. 2020 Jun;40(6):909-915. doi: 10.1038/s41372-020-0632-2. Epub 2020 Feb 21.
PubMed 32086439Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL. A pacifier-activated music player with mother's voice improves oral feeding in preterm infants. Pediatrics. 2014 Mar;133(3):462-8. doi: 10.1542/peds.2013-2547. Epub 2014 Feb 17.
PubMed 24534413Glackin SJ, O'Sullivan A, George S, Semberova J, Miletin J. High flow nasal cannula versus NCPAP, duration to full oral feeds in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2017 Jul;102(4):F329-F332. doi: 10.1136/archdischild-2016-311388. Epub 2016 Dec 23.
PubMed 28011792Hanin M, Nuthakki S, Malkar MB, Jadcherla SR. Safety and Efficacy of Oral Feeding in Infants with BPD on Nasal CPAP. Dysphagia. 2015 Apr;30(2):121-7. doi: 10.1007/s00455-014-9586-x. Epub 2014 Nov 8.
PubMed 25380678Hatch LD 3rd, Clark RH, Carlo WA, Stark AR, Ely EW, Patrick SW. Changes in Use of Respiratory Support for Preterm Infants in the US, 2008-2018. JAMA Pediatr. 2021 Oct 1;175(10):1017-1024. doi: 10.1001/jamapediatrics.2021.1921.
PubMed 34228110Jain D, Bancalari E. New Developments in Respiratory Support for Preterm Infants. Am J Perinatol. 2019 Jul;36(S 02):S13-S17. doi: 10.1055/s-0039-1691817. Epub 2019 Jun 25.
PubMed 31238352
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05446389
- Acronym / sponsor ID
- 2091032
- Conditions
- Chronic Lung Disease of Prematurity, Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia, Preterm Birth
- Keywords
- Music Therapy, NICU, Pacifier Activated Lullaby, Premature Infant, Chronic Lung Disease, Oral Feeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution \& the study was closed.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- University of Georgia
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infants in the Neonatal Intensive Care Unit at MU Healthcare receive consultations for music therapy services upon admission. The PAL intervention used in this study is a part of routine care that would happen regardless of participation in this study. The Music Therapist will discuss study with the parents of infants who meet inclusion criteria between 32 to 34 weeks PMA.
Clinical all infants on non-invasive respiratory support have a room air trial at 34 weeks PMA. Infants who fail their room air trail and are still on non-invasive respiratory support that is >2L will be randomized to either the control or intervention group. The control group will receive no additional intervention.
The experimental group will begin 2 PAL sessions per gestation week of age such that infants receive two sessions between 34 0/7 and 34 6/7, two sessions between 35 0/7 and 35 6/7, etc. When the infant is on <2L of respiratory support they will receive one more PAL session within 24 hours prior to their first oral feeding attempt.Infants in the experimental group will receive no additional PAL sessions after they begin oral feeding trials. PAL sessions will utilize the Pacifier Activated Lullaby device (PAL®) that is an FDA cleared medical device for use with preterm infants in the NICU. Sessions will be 15 minutes in length and be during the infant's gavage feed.The music therapist will get approval from the bedside RN prior to beginning any PAL sessions.The infant will be prompted with the pacifier by touching the pacifier to the infant's lips. If the infant doesn't accept pacifier in mouth after 3 attempts the music therapy will gently stroke the infant's cheeks to prompt the rooting reflex and then prompt with the pacifier. If the infant doesn't accept the pacifier in their mouth, then the music therapist will stop the session attempt and it will not count as a PAL session. If the infant pauses in non-nutritive sucking (NNS) for more than 30 seconds with music therapist will prompt the infant by moving pacifier in infant's mouth. This will be attempted 3 times if needed. If the infant still doesn't engage in NNS then the music therapy will stroke the infant's cheek and then move pacifier in mouth. This will be done twice. If the infant still does not engage in NNS then the session will be ended. The session will count if it lasted 8 minutes in length prior to the music therapist beginning prompting. If it was less than 8 minutes then it will not count towards a completed PAL session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Pacifier Activated Lullaby ®Infants randomized in to the experimental group will receive the PAL intervention 2 times a week until the infant transitions to room air or < 2L high flow nasal cannula and is able to begin attempting feeds by mouth. The PAL is an FDA cleared medical device that has a sensor that will connect to the infant's pacifier and can read the infant's suck. Then, the device plays music as positive reinforcement to help improve sucking skills. This intervention typically lasts about 15 minutes and is implemented while the infant is receiving gavage feeds. |
| Control Group | No intervention | –Infants randomized in to the control group will not receive music therapy intervention throughout NICU admission. |
Who may qualify
- Ages
- 1 day to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention Group |
Primary outcome
Oral Feeding
Time frame: 1-6 weeks
Time to full transition from gavage to oral feeding by mouth as measured by days
2 secondary outcomes
Length of Stay
Time frame: 1-8 months
Length of Respiratory Support
Time frame: 1-16 weeks
Results and safety
The study was stopped early (reason given: PI left the institution \& the study was closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 32086439Dumpa V, Kamity R, Ferrara L, Akerman M, Hanna N. The effects of oral feeding while on nasal continuous positive airway pressure (NCPAP) in preterm infants. J Perinatol. 2020 Jun;40(6):909-915. doi: 10.1038/s41372-020-0632-2. Epub 2020 Feb 21.
- Background: PubMed 24534413Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL. A pacifier-activated music player with mother's voice improves oral feeding in preterm infants. Pediatrics. 2014 Mar;133(3):462-8. doi: 10.1542/peds.2013-2547. Epub 2014 Feb 17.
- Background: PubMed 28011792Glackin SJ, O'Sullivan A, George S, Semberova J, Miletin J. High flow nasal cannula versus NCPAP, duration to full oral feeds in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2017 Jul;102(4):F329-F332. doi: 10.1136/archdischild-2016-311388. Epub 2016 Dec 23.
- Background: PubMed 25380678Hanin M, Nuthakki S, Malkar MB, Jadcherla SR. Safety and Efficacy of Oral Feeding in Infants with BPD on Nasal CPAP. Dysphagia. 2015 Apr;30(2):121-7. doi: 10.1007/s00455-014-9586-x. Epub 2014 Nov 8.
- Background: PubMed 34228110Hatch LD 3rd, Clark RH, Carlo WA, Stark AR, Ely EW, Patrick SW. Changes in Use of Respiratory Support for Preterm Infants in the US, 2008-2018. JAMA Pediatr. 2021 Oct 1;175(10):1017-1024. doi: 10.1001/jamapediatrics.2021.1921.
- Background: PubMed 31238352Jain D, Bancalari E. New Developments in Respiratory Support for Preterm Infants. Am J Perinatol. 2019 Jul;36(S 02):S13-S17. doi: 10.1055/s-0039-1691817. Epub 2019 Jun 25.
- Individual participant dataSharing planned: No. We have no plan to make IPD available to other researchers.
Related trials for Chronic Lung Disease of Prematurity
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Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacifier Activated Lullaby ® in people with Chronic Lung Disease of Prematurity and Respiratory Distress Syndrome in Premature Infant, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left the institution \& the study was closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Feeding (time frame: 1-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446389, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.