The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Overall Transfer (OT):
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 34 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Pacifier-Activated Lullaby (PAL) Therapy (Device)
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.
结局指标
主要结局
Overall Transfer (OT):
时间窗: Baseline (Day 0) through completion of the intervention period (Day 14)
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
Proficiency (PRO)
时间窗: Baseline (Day 0) through completion of the intervention period (Day 14)
Milk volume consumed during the first 5 minutes divided by the prescribed volume of each feed, expressed as a percentage
Endurance (rate of transfer)
时间窗: Baseline (Day 0) through completion of the intervention period (Day 14)
Endurance (rate of milk transfer) expressed as ml/min
次要结局
- 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))
研究者
Sreekanth Viswanathan
Neonatologist
Nemours Children's Clinic