The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
ConditionDysphagia of Newborn
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age34-36
SponsorNemours Children's Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pacifier-Activated Lullaby (PAL) Therapy
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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Pacifier-Activated Lullaby (PAL) Plus Standard Feeding CareExperimental treatment 1 intervention
Group B: Standard Feeding Care AloneNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)2
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)3
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)Secondary outcomes
1
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 randomization2
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 randomization3
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)Sponsors and contacts
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Source ClinicalTrials.gov