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RECRUITING
NCT07819734
NA

The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants

Sponsor: Nemours Children's Clinic

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

All

Age Range

34 Weeks - 36 Weeks

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2020-11-16

Completion Date

2027-03-31

Last Updated

2026-09-15

Healthy Volunteers

Yes

Interventions

DEVICE

Pacifier-Activated Lullaby (PAL) Therapy

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.

Locations (1)

Nemours Children's Hospital, Florida

Orlando, Florida, United States