An interventional study of Pacifier-Activated Lullaby (PAL) Therapy in Dysphagia of Newborn, sponsored by Nemours Children's Clinic. Recruiting at 1 site in United States. Open to participants aged 34 Weeks to 36 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Pacifier-Activated Lullaby (PAL) Therapy
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.
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.
Also known as: Auditory Reinforcement of Non-Nutritive Sucking Using a Pacifier-Activated Lullaby Device
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
Time frame: 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
Time frame: Baseline (Day 0) through completion of the intervention period (Day 14)
Endurance (rate of transfer)
Endurance (rate of milk transfer) expressed as ml/min
Time frame: Baseline (Day 0) through completion of the intervention period (Day 14)
Days to Full Oral Feeding
Number of days required for participants to achieve full oral feeding without the need for supplemental gavage (tube) 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
Number of days participants required gavage (tube) feeding support during the study period.
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
Change in body weight during the study period, including daily weight measurements, to assess the effect of PAL therapy on growth.
Time frame: Baseline (Day 0) through completion of the intervention period (Day 14)
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: Available upon publication of the primary manuscript and for up to 5 years thereafter
Access criteria: De-identified individual participant data (IPD) underlying the results reported in publications arising from this study may be made available to qualified researchers upon reasonable request. Requests must include a scientifically sound research proposal and will be reviewed by the study investigators and Nemours Children's Health. Access may require approval by the appropriate institutional review board (IRB) and execution of a data use agreement. Only de-identified data and supporting study documentation necessary to conduct the approved analyses will be provided. Data will be shared through a secure electronic transfer method that complies with institutional privacy and security requirements.
Data sharing details ↗ · www.nemours.org
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