The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
Purpose
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.
Condition
- Dysphagia of Newborn
Eligibility
- Eligible Ages
- Between 34 Weeks and 36 Weeks
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This study used a parallel-group randomized controlled design conducted in a single Level IV Neonatal Intensive Care Unit (NICU). Eligible preterm infants were randomly assigned in a 1:1 ratio to either (1) Pacifier-Activated Lullaby (PAL) therapy plus standard feeding care or (2) standard feeding care alone. Randomization occurred after confirmation of eligibility and parental informed consent. The clinical care team remained blinded to treatment assignment. Infants assigned to the intervention group received PAL sessions in which a pressure-sensitive pacifier activated playback of a recorded maternal or caregiver voice when a predetermined sucking threshold was achieved, providing positive reinforcement for non-nutritive sucking. Infants assigned to the control group received routine NICU care, including standard opportunities for non-nutritive sucking and oral feeding advancement according to unit practices. Participants were followed longitudinally during the intervention period to
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The clinical care team responsible for routine patient management and feeding advancement was blinded to study group assignment throughout the study period. Group allocation was concealed from bedside nurses, neonatologists, nurse practitioners, and other healthcare providers involved in daily clinical decision-making to minimize the potential for differential treatment between groups. Outcome data were collected using standardized feeding assessments and clinical measurements obtained as part of routine care. Parents were informed of study participation and provided consent; however, they were not involved in outcome assessment or data analysis. The specific intervention assignment was not disclosed to members of the clinical team responsible for patient care, and study procedures were conducted by trained research personnel and the music therapist.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Orlando, Florida 32827
More Details
- Status
- Recruiting
- Sponsor
- Nemours Children's Clinic
Detailed Description
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.