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

RecruitingNAAges 34 Weeks - 36 WeeksAllNemours Children's Clinic
NCT07819734 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 com

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📋 Eligibility rules (as published)
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
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What it tests

  • Pacifier-Activated Lullaby (PAL) Therapy
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Where

1 site
Nemours Children's Hospital, Florida
Orlando, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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