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

Nemours Children's Clinic · NCT07819734

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 8 mo–8 mo · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
46
US sites recruiting
1
Study start
November 16, 2020
Record last updated
September 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Pacifier-Activated Lullaby (PAL) Therapy

Conditions: Dysphagia of Newborn

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Nemours Children's Hospital, Florida

    Orlando, FL 32827

    Site contact: Caroline Chua, MD · 407-307-6786 · caroline.chua@nemours.org

Study contacts (from the official record)

  • Caroline Chua, MD · 407-307-6786 · caroline.chua@nemours.org
  • Sreekanth Viswanathan, MD · 4076977603 · sreekanth.viswanathan@nemours.org
All pregnancy studies in Florida →
The Effects of Pacifier-Activated Lullaby on Oral Feeding Among… (NCT07819734) | Bored Studies