Recruiting

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

Sponsor:

Nemours Children's Clinic

Code:

NCT07819734

Conditions

Dysphagia of Newborn

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Pacifier-Activated Lullaby (PAL) Therapy

Study Details

Brief 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.

Conditions

Dysphagia of Newborn

Study ID

NCT07819734

Start date

Nov 16, 2020

Status verified date

Sep, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pacifier-Activated Lullaby (PAL) Plus Standard Feeding Care

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.

no intervention: Standard Feeding Care Alone

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.

Interventions

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.

Primary outcome measure

Overall Transfer (OT): [ Time Frame: Baseline (Day 0) through completion of the intervention period (Day 14) ]
Proficiency (PRO) [ Time Frame: Baseline (Day 0) through completion of the intervention period (Day 14) ]
Endurance (rate of transfer) [ Time Frame: Baseline (Day 0) through completion of the intervention period (Day 14) ]

Central Contacts and Locations

Central contacts

Caroline Chua, MD

407-307-6786 caroline.chua@nemours.org

Sreekanth Viswanathan, MD

4076977603 sreekanth.viswanathan@nemours.org

Locations

Nemours Children's Hospital, Florida

Recruiting

Orlando, Florida, United States, 32827

Contacts

Caroline Chua, MD

407-307-6786 caroline.chua@nemours.org

Sreekanth Viswanathan, MD

4074930706 sreekanth.viswanathan@nemours.org

Principal Investigator:

Caroline Chua, MD

More Information

Sponsor

Nemours Children's Clinic

Last update posted

Sep 15, 2026

Last verified

Sep, 2026

Keywords

Prematurity
Feeding Difficulties
Oral Feeding Disorder
Music therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by Nemours Children's Clinic on 2026-09-15.