NCT07819734|RecruitingFDA Device
The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
Music therapy
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Music therapy
Sponsor study identifier
interventional
46
1 country
1
Study Start
November 16, 2020
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 16, 2020
Actual (reported)August 31, 2026
Actual (reported)September 15, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Baseline (Day 0) through completion of the intervention period (Day 14)
Endurance (rate of transfer)
Endurance (rate of milk transfer) expressed as ml/min
Baseline (Day 0) through completion of the intervention period (Day 14)
Days to Full Oral Feeding
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
From randomization until achievement of full oral feeding or hospital discharge, whichever occurred first for up to 15 weeks from randomization
Daily Weight Gain
Baseline (Day 0) through completion of the intervention period (Day 14)
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Nemours Children's Hospital, Florida
Orlando, Florida, 32827, United States
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.
Yildiz 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.
Caroline Chua, MD
Nemours Children's Hospital
Contact the study team to confirm eligibility.
Shokri 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.
Chorna 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.
Zhao 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.
Tubbs-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.
Bakker 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.
First Submitted
August 31, 2026
First Posted
September 15, 2026
Study Start
November 16, 2020
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 15, 2026
Record last verified: 2026-09
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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Source: ClinicalTrials.gov.
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