Dysphagia of NewbornMusic therapyNCT07819734
The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
A study testing Pacifier-Activated Lullaby (PAL) Therapy in people with Dysphagia of Newborn, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Preterm infants often have difficulty learning how to feed by mouth because the coordination of sucking, swallowing, and breathing develops later in pregnancy. Delays in achieving full oral feeding can prolong hospitalization and increase the need for tube feeding. Read more about this study
- Who is it for?
- Ages 34 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Dysphagia of Newborn
- What is being tested?
- Pacifier-Activated Lullaby (PAL) Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 34 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants born at less than 32 weeks gestational age
- Postmenstrual age between 34 0/7 and 35 6/7 weeks at enrollment
- Receiving at least half of nutritional intake enterally and less than half orally
- Written informed consent obtained from parent(s) or legal guardian(s)
Who cannot join
- Mechanical ventilation at enrollment
- Continuous positive airway pressure (CPAP) support
- High-flow nasal cannula support >2 L/min
- Determined by the treating medical team to be unsafe for oral feeding
- Determined by feeding or speech specialists to be unsafe for oral feeding
- Clinical instability preventing participation in study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Hospital, Florida
Orlando, Florida, 32827
Caroline Chua, MD, 407-307-6786, caroline.chua@nemours.org
Sreekanth Viswanathan, MD, 4074930706, sreekanth.viswanathan@nemours.org
About this study
Preterm infants often have difficulty learning how to feed by mouth because the coordination of sucking, swallowing, and breathing develops later in pregnancy. Delays in achieving full oral feeding can prolong hospitalization and increase the need for tube feeding.
This study evaluated whether a Pacifier-Activated Lullaby (PAL) system could improve oral feeding performance in preterm infants. The PAL device plays a recorded maternal or caregiver voice when an infant generates an adequate non-nutritive suck on a pacifier, providing positive reinforcement during feeding development.
Read more
In this randomized controlled trial conducted at Nemours Children's Hospital in Orlando, Florida, preterm infants who were transitioning from tube feeding to oral feeding were assigned either to receive PAL therapy in addition to standard feeding care or to receive standard feeding care alone. Researchers compared measures of oral feeding performance, feeding efficiency, growth, and progression toward independent oral feeding between the two groups.
The goal of the study was to determine whether reinforcing non-nutritive sucking with auditory feedback could enhance feeding development and improve clinical outcomes in preterm infants. The information gained from this study may help clinicians better understand the role of music-assisted feeding interventions in neonatal care and identify which infants are most likely to benefit from this approach.
Read the detailed description
Premature infants frequently experience feeding difficulties because the coordination of sucking, swallowing, and breathing develops during the later stages of gestation. Many infants born very preterm require prolonged tube feeding before they can safely and effectively feed by mouth. Delays in the transition from tube feeding to full oral feeding may contribute to prolonged hospitalization, increased healthcare utilization, and challenges in growth and development.
Non-nutritive sucking (NNS), such as sucking on a pacifier without receiving nutrition, is considered an important developmental precursor to oral feeding. Previous studies have suggested that NNS may improve feeding readiness, support maturation of oral motor skills, and facilitate the transition to oral feeding. Researchers have also explored whether positive reinforcement techniques can further enhance these feeding behaviors.
The Pacifier-Activated Lullaby (PAL) system is an FDA-cleared device designed to reinforce non-nutritive sucking through auditory feedback. The system consists of a pressure-sensitive pacifier connected to a music player. When an infant generates a suck that meets a predefined threshold, the device plays a recorded voice, typically the infant's mother singing lullabies. The intervention is based on principles of operant conditioning, with the auditory stimulus serving as a reward for effective sucking behavior.
This study was designed to evaluate whether PAL therapy improves oral feeding performance in preterm infants compared with standard neonatal feeding care alone. The trial was conducted in the Level IV Neonatal Intensive Care Unit (NICU) at Nemours Children's Hospital in Orlando, Florida.
Eligible participants were preterm infants born at less than 32 weeks gestational age who had reached approximately 34 to 36 weeks postmenstrual age and were transitioning from tube feeding to oral feeding. Infants were required to be receiving a substantial portion of their nutrition enterally while still developing oral feeding skills. Infants requiring significant respiratory support or considered unsafe for oral feeding were excluded.
Participants were randomly assigned to either the intervention group or the control group. Infants in the intervention group received PAL therapy in addition to standard feeding care. During PAL sessions, a recording of the mother's voice or a caregiver's voice was played whenever the infant generated an adequate non-nutritive suck on the PAL pacifier. Infants in the control group received standard feeding care, including routine opportunities for non-nutritive sucking and developmental care practices used in the NICU.
Researchers evaluated multiple measures of feeding performance, including oral feeding proficiency, feeding efficiency, milk transfer, feeding duration, growth, progression toward full oral feeding, and related clinical outcomes. Safety was monitored throughout the study, and PAL sessions were discontinued if infants exhibited signs of physiologic instability or feeding intolerance.
The purpose of this study was to determine whether reinforcing non-nutritive sucking with an auditory reward could accelerate the development of feeding skills and improve clinical outcomes in preterm infants. The findings may help clinicians better understand the role of music-assisted and behavioral reinforcement interventions in neonatal feeding therapy and identify patient populations most likely to benefit from these approaches.
- Conditions
- Dysphagia of Newborn
- Being tested
- Pacifier-Activated Lullaby (PAL) Therapy
- Keywords
- Prematurity, Feeding Difficulties, Oral Feeding Disorder, Music therapy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacifier-Activated Lullaby (PAL) TherapyDevice
Also called Auditory Reinforcement of Non-Nutritive Sucking Using a Pacifier-Activated Lullaby Device
The Pacifier-Activated Lullaby (PAL) intervention is a device-based feeding therapy designed to reinforce non-nutritive sucking in preterm infants through contingent auditory feedback. The PAL system consists of a pressure-sensitive pacifier connected to a digital music player. When the infant generates a suck that meets a predetermined pressure threshold, the device automatically plays a prerecorded maternal or caregiver voice, typically lullabies or children's songs, providing positive reinforcement for effective sucking behavior.
Infants assigned to the intervention arm received PAL therapy in addition to standard neonatal intensive care unit (NICU) feeding care. Maternal voice recordings were obtained before initiation of therapy and uploaded to the PAL device. During intervention sessions, the infant was offered the PAL pacifier approximately 30-45 minutes before scheduled feedings. Auditory stimulation was activated only when the infant achieved the predefined sucking threshold.
| Study group | Role | What they receive |
|---|---|---|
| Pacifier-Activated Lullaby (PAL) Plus Standard Feeding Care | Experimental | Preterm infants randomized to this arm received Pacifier-Activated Lullaby (PAL) therapy in addition to standard neonatal intensive care unit (NICU) feeding practices. The PAL device used a pressure-sensitive pacifier that activated playback of a recorded maternal or caregiver voice when the infant generated a predetermined non-nutritive sucking threshold. PAL sessions were administered by trained study personnel while infants continued to receive routine developmental care, non-nutritive sucking opportunities, and oral feeding advancement according to NICU protocols. Receives: Device: Pacifier-Activated Lullaby (PAL) Therapy |
| Standard Feeding Care Alone | No intervention | Preterm infants randomized to this arm received standard NICU feeding care without use of the Pacifier-Activated Lullaby device. Standard care included routine developmental care, opportunities for non-nutritive sucking using a conventional pacifier, nursing care, parental involvement, and advancement of oral feeding according to established NICU feeding practices and clinical judgment. Participants underwent the same outcome assessments as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Transfer (OT):
Assessment of overall milk transfer before and after the intervention. Overall Transfer (OT): volume consumed divided by the prescribed volume of each feed expressed as a percentage
Measured: Baseline (Day 0) through completion of the intervention period (Day 14)
Proficiency (PRO)
Milk volume consumed during the first 5 minutes divided by the prescribed volume of each feed, expressed as a percentage
Measured: Baseline (Day 0) through completion of the intervention period (Day 14)
Endurance (rate of transfer)
Endurance (rate of milk transfer) expressed as ml/min
Measured: Baseline (Day 0) through completion of the intervention period (Day 14)
Secondary outcomes (3)
Days to Full Oral Feeding
Number of days required for participants to achieve full oral feeding without the need for supplemental gavage (tube) feeding.
Measured: From randomization until achievement of full oral feeding or hospital discharge, whichever occurred first, for up to 15 weeks from randomization
Number of Gavage Feeding Days
Number of days participants required gavage (tube) feeding support during the study period.
Measured: From randomization until achievement of full oral feeding or hospital discharge, whichever occurred first for up to 15 weeks from randomization
Daily Weight Gain
Change in body weight during the study period, including daily weight measurements, to assess the effect of PAL therapy on growth.
Measured: Baseline (Day 0) through completion of the intervention period (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start16 Nov 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dysphagia of NewbornStudies of the same condition, open and under way.
- 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 used a parallel-group randomized controlled design conducted in a single Level IV Neonatal Intensive Care Unit (NICU). Eligible preterm infants were randomly assigned in a 1:1 ratio to either (1) Pacifier-Activated Lullaby (PAL) therapy plus standard feeding care or (2) standard feeding care alone. Randomization occurred after confirmation of eligibility and parental informed consent. The clinical care team remained blinded to treatment assignment. Infants assigned to the intervention group received PAL sessions in which a pressure-sensitive pacifier activated playback of a recorded maternal or caregiver voice when a predetermined sucking threshold was achieved, providing positive reinforcement for non-nutritive sucking. Infants assigned to the control group received routine NICU care, including standard opportunities for non-nutritive sucking and oral feeding advancement according to unit practices. Participants were followed longitudinally during the intervention period to
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sreekanth Viswanathan, Nemours Children's Clinic
- Investigators
- Caroline Chua, MD, Principal investigator, Nemours Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819734
- Sponsor's protocol ID
- 1568970-9
- Acronym
- Music therapy
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications arising from this study may be shared with qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and institution and may require a data use agreement to protect participant confidentiality. No directly identifiable participant information will be shared.
Publications
Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.
PubMed 27699765Yildiz A, Arikan D. The effects of giving pacifiers to premature infants and making them listen to lullabies on their transition period for total oral feeding and sucking success. J Clin Nurs. 2012 Mar;21(5-6):644-56. doi: 10.1111/j.1365-2702.2010.03634.x. Epub 2011 Jun 13.
PubMed 21668549Shokri E, Zarifian T, Soleimani F, Knoll BL, Mosayebi Z, Noroozi M, GhasrHamidi K, Pascoe M. Effect of premature infant oral motor intervention [PIOMI] combined with music therapy on feeding progression of preterm infants: a randomized control trial. Eur J Pediatr. 2023 Dec;182(12):5681-5692. doi: 10.1007/s00431-023-05237-0. Epub 2023 Oct 12.
PubMed 37823927Chorna 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 24534413Zhao S, Jiang H, Miao Y, Liu W, Li Y, Zhang Y, Wang A, Cui X. Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis. PLoS One. 2024 Apr 16;19(4):e0302267. doi: 10.1371/journal.pone.0302267. eCollection 2024.
PubMed 38626172Tubbs-Cooley HL, Pickler RH, Meinzen-Derr JK. Missed oral feeding opportunities and preterm infants' time to achieve full oral feedings and neonatal intensive care unit discharge. Am J Perinatol. 2015 Jan;32(1):1-8. doi: 10.1055/s-0034-1372426. Epub 2014 Mar 28.
PubMed 24683073Bakker L, Jackson B, Miles A. Oral-feeding guidelines for preterm neonates in the NICU: a scoping review. J Perinatol. 2021 Jan;41(1):140-149. doi: 10.1038/s41372-020-00887-6. Epub 2020 Dec 7.
PubMed 33288867
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
- ClinicalTrials.gov ID
- NCT07819734
- Acronym / sponsor ID
- Music therapy / 1568970-9
- Conditions
- Dysphagia of Newborn
- Keywords
- Prematurity, Feeding Difficulties, Oral Feeding Disorder, Music therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Sep 2026 (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.
Preterm infants often have difficulty learning how to feed by mouth because the coordination of sucking, swallowing, and breathing develops later in pregnancy. Delays in achieving full oral feeding can prolong hospitalization and increase the need for tube feeding.
This study evaluated whether a Pacifier-Activated Lullaby (PAL) system could improve oral feeding performance in preterm infants. The PAL device plays a recorded maternal or caregiver voice when an infant generates an adequate non-nutritive suck on a pacifier, providing positive reinforcement during feeding development.
In this randomized controlled trial conducted at Nemours Children's Hospital in Orlando, Florida, preterm infants who were transitioning from tube feeding to oral feeding were assigned either to receive PAL therapy in addition to standard feeding care or to receive standard feeding care alone. Researchers compared measures of oral feeding performance, feeding efficiency, growth, and progression toward independent oral feeding between the two groups.
The goal of the study was to determine whether reinforcing non-nutritive sucking with auditory feedback could enhance feeding development and improve clinical outcomes in preterm infants. The information gained from this study may help clinicians better understand the role of music-assisted feeding interventions in neonatal care and identify which infants are most likely to benefit from this approach.
Detailed description
Premature infants frequently experience feeding difficulties because the coordination of sucking, swallowing, and breathing develops during the later stages of gestation. Many infants born very preterm require prolonged tube feeding before they can safely and effectively feed by mouth. Delays in the transition from tube feeding to full oral feeding may contribute to prolonged hospitalization, increased healthcare utilization, and challenges in growth and development.
Non-nutritive sucking (NNS), such as sucking on a pacifier without receiving nutrition, is considered an important developmental precursor to oral feeding. Previous studies have suggested that NNS may improve feeding readiness, support maturation of oral motor skills, and facilitate the transition to oral feeding. Researchers have also explored whether positive reinforcement techniques can further enhance these feeding behaviors.
The Pacifier-Activated Lullaby (PAL) system is an FDA-cleared device designed to reinforce non-nutritive sucking through auditory feedback. The system consists of a pressure-sensitive pacifier connected to a music player. When an infant generates a suck that meets a predefined threshold, the device plays a recorded voice, typically the infant's mother singing lullabies. The intervention is based on principles of operant conditioning, with the auditory stimulus serving as a reward for effective sucking behavior.
This study was designed to evaluate whether PAL therapy improves oral feeding performance in preterm infants compared with standard neonatal feeding care alone. The trial was conducted in the Level IV Neonatal Intensive Care Unit (NICU) at Nemours Children's Hospital in Orlando, Florida.
Eligible participants were preterm infants born at less than 32 weeks gestational age who had reached approximately 34 to 36 weeks postmenstrual age and were transitioning from tube feeding to oral feeding. Infants were required to be receiving a substantial portion of their nutrition enterally while still developing oral feeding skills. Infants requiring significant respiratory support or considered unsafe for oral feeding were excluded.
Participants were randomly assigned to either the intervention group or the control group. Infants in the intervention group received PAL therapy in addition to standard feeding care. During PAL sessions, a recording of the mother's voice or a caregiver's voice was played whenever the infant generated an adequate non-nutritive suck on the PAL pacifier. Infants in the control group received standard feeding care, including routine opportunities for non-nutritive sucking and developmental care practices used in the NICU.
Researchers evaluated multiple measures of feeding performance, including oral feeding proficiency, feeding efficiency, milk transfer, feeding duration, growth, progression toward full oral feeding, and related clinical outcomes. Safety was monitored throughout the study, and PAL sessions were discontinued if infants exhibited signs of physiologic instability or feeding intolerance.
The purpose of this study was to determine whether reinforcing non-nutritive sucking with an auditory reward could accelerate the development of feeding skills and improve clinical outcomes in preterm infants. The findings may help clinicians better understand the role of music-assisted and behavioral reinforcement interventions in neonatal feeding therapy and identify patient populations most likely to benefit from these approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a parallel-group randomized controlled design conducted in a single Level IV Neonatal Intensive Care Unit (NICU). Eligible preterm infants were randomly assigned in a 1:1 ratio to either (1) Pacifier-Activated Lullaby (PAL) therapy plus standard feeding care or (2) standard feeding care alone. Randomization occurred after confirmation of eligibility and parental informed consent. The clinical care team remained blinded to treatment assignment. Infants assigned to the intervention group received PAL sessions in which a pressure-sensitive pacifier activated playback of a recorded maternal or caregiver voice when a predetermined sucking threshold was achieved, providing positive reinforcement for non-nutritive sucking. Infants assigned to the control group received routine NICU care, including standard opportunities for non-nutritive sucking and oral feeding advancement according to unit practices. Participants were followed longitudinally during the intervention period to
| Arm | Type | Receives |
|---|---|---|
| Pacifier-Activated Lullaby (PAL) Plus Standard Feeding Care | Experimental | Device: Pacifier-Activated Lullaby (PAL) TherapyPreterm infants randomized to this arm received Pacifier-Activated Lullaby (PAL) therapy in addition to standard neonatal intensive care unit (NICU) feeding practices. The PAL device used a pressure-sensitive pacifier that activated playback of a recorded maternal or caregiver voice when the infant generated a predetermined non-nutritive sucking threshold. PAL sessions were administered by trained study personnel while infants continued to receive routine developmental care, non-nutritive sucking opportunities, and oral feeding advancement according to NICU protocols. |
| Standard Feeding Care Alone | No intervention | –Preterm infants randomized to this arm received standard NICU feeding care without use of the Pacifier-Activated Lullaby device. Standard care included routine developmental care, opportunities for non-nutritive sucking using a conventional pacifier, nursing care, parental involvement, and advancement of oral feeding according to established NICU feeding practices and clinical judgment. Participants underwent the same outcome assessments as the intervention group. |
Who may qualify
- Ages
- 34 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants born at less than 32 weeks gestational age
- Postmenstrual age between 34 0/7 and 35 6/7 weeks at enrollment
- Receiving at least half of nutritional intake enterally and less than half orally
- Written informed consent obtained from parent(s) or legal guardian(s)
Key exclusion criteria (6 listed)
- Mechanical ventilation at enrollment
- Continuous positive airway pressure (CPAP) support
- High-flow nasal cannula support >2 L/min
- Determined by the treating medical team to be unsafe for oral feeding
- Determined by feeding or speech specialists to be unsafe for oral feeding
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 (PAL) TherapyAlso: Auditory Reinforcement of Non-Nutritive Sucking Using a Pacifier-Activated Lullaby DeviceThe Pacifier-Activated Lullaby (PAL) intervention is a device-based feeding therapy designed to reinforce non-nutritive sucking in preterm infants through contingent auditory feedback. The PAL system consists of a pressure-sensitive pacifier connected to a digital music player. When the infant generates a suck that meets a predetermined pressure threshold, the device automatically plays a prerecorded maternal or caregiver voice, typically lullabies or children's songs, providing positive reinforcement for effective sucking behavior. Infants assigned to the intervention arm received PAL therapy in addition to standard neonatal intensive care unit (NICU) feeding care. Maternal voice recordings were obtained before initiation of therapy and uploaded to the PAL device. During intervention sessions, the infant was offered the PAL pacifier approximately 30-45 minutes before scheduled feedings. Auditory stimulation was activated only when the infant achieved the predefined sucking threshold. | Device | Pacifier-Activated Lullaby (PAL) Plus Standard Feeding Care |
Primary outcome
Overall Transfer (OT):
Time frame: Baseline (Day 0) through completion of the intervention period (Day 14)
Assessment of overall milk transfer before and after the intervention. Overall Transfer (OT): volume consumed divided by the prescribed volume of each feed expressed as a percentage
Proficiency (PRO)
Time frame: Baseline (Day 0) through completion of the intervention period (Day 14)
Milk volume consumed during the first 5 minutes divided by the prescribed volume of each feed, expressed as a percentage
Endurance (rate of transfer)
Time frame: Baseline (Day 0) through completion of the intervention period (Day 14)
Endurance (rate of milk transfer) expressed as ml/min
3 secondary outcomes
Days to Full Oral Feeding
Time frame: From randomization until achievement of full oral feeding or hospital discharge, whichever occurred first, for up to 15 weeks from randomization
Number of Gavage Feeding Days
Time frame: From randomization until achievement of full oral feeding or hospital discharge, whichever occurred first for up to 15 weeks from randomization
Daily Weight Gain
Time frame: Baseline (Day 0) through completion of the intervention period (Day 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 27699765Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.
- Background: PubMed 21668549Yildiz A, Arikan D. The effects of giving pacifiers to premature infants and making them listen to lullabies on their transition period for total oral feeding and sucking success. J Clin Nurs. 2012 Mar;21(5-6):644-56. doi: 10.1111/j.1365-2702.2010.03634.x. Epub 2011 Jun 13.
- Background: PubMed 37823927Shokri E, Zarifian T, Soleimani F, Knoll BL, Mosayebi Z, Noroozi M, GhasrHamidi K, Pascoe M. Effect of premature infant oral motor intervention [PIOMI] combined with music therapy on feeding progression of preterm infants: a randomized control trial. Eur J Pediatr. 2023 Dec;182(12):5681-5692. doi: 10.1007/s00431-023-05237-0. Epub 2023 Oct 12.
- 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 38626172Zhao S, Jiang H, Miao Y, Liu W, Li Y, Zhang Y, Wang A, Cui X. Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis. PLoS One. 2024 Apr 16;19(4):e0302267. doi: 10.1371/journal.pone.0302267. eCollection 2024.
- Background: PubMed 24683073Tubbs-Cooley HL, Pickler RH, Meinzen-Derr JK. Missed oral feeding opportunities and preterm infants' time to achieve full oral feedings and neonatal intensive care unit discharge. Am J Perinatol. 2015 Jan;32(1):1-8. doi: 10.1055/s-0034-1372426. Epub 2014 Mar 28.
- Background: PubMed 33288867Bakker L, Jackson B, Miles A. Oral-feeding guidelines for preterm neonates in the NICU: a scoping review. J Perinatol. 2021 Jan;41(1):140-149. doi: 10.1038/s41372-020-00887-6. Epub 2020 Dec 7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications arising from this study may be shared with qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and institution and may require a data use agreement to protect participant confidentiality. No directly identifiable participant information will be shared.
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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.
Caroline Chua, MD principal investigator
Nemours Children's Hospital
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 (PAL) Therapy in people with Dysphagia of Newborn, run by Nemours Children's Clinic 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Chua, MD (407-307-6786, caroline.chua@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Transfer (OT): (time frame: Baseline (Day 0) through completion of the intervention period (Day 14)). The study lists 3 primary outcomes in all. 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 NCT07819734, which also lists 7 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 15 Sep 2026.