Pacifier-Activated Lullaby to support oral feeding in preterm infants
Official title: The Effects of Pacifier-Activated Lullaby on Oral Feeding Among Preterm Infants
Run by Nemours Children's Clinic · NCT07819734 · Data updated 2026-11-12
This study tests whether a pacifier-activated lullaby system helps preterm babies move from tube feeding to feeding by mouth.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 34 Weeks to 36 Weeks |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Status | Recruiting |
| Started | November 16, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT07819734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm infants born before 32 weeks gestation and currently transitioning from tube to oral feeding, with enough stability to attempt oral feeds.
✕Probably not a fit
Infants who are still on high levels of respiratory support or unstable for feeding may not benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In preterm infants, coordinating sucking, swallowing, and breathing is still developing, which can delay safe oral feeding. The trial compares PAL therapy plus standard feeding care to standard feeding care alone in preterm infants transitioning from tube feeding. The PAL device plays a caregiver’s voice when the infant sufficiently sucks on a pacifier, providing positive reinforcement. Outcomes include oral feeding performance, feeding efficiency, growth, and progression toward independent feeding. The study was conducted at Nemours Children's Hospital in Orlando, Florida.
Why it matters
Potential benefit: If successful, PAL therapy could shorten time to full oral feeding and reduce hospital stay for preterm infants.
How similar studies have gone: Prior research suggests non-nutritive sucking and positive reinforcement may aid feeding readiness, but results for PAL in this specific setting are mixed.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Nemours Children's Hospital, Florida
Orlando, Florida, United States Recruiting
Study contacts
- Principal investigator: Caroline Chua, MD — Nemours Children's Hospital
- Study coordinator: Caroline Chua, MD
- Email: caroline.chua@nemours.org
- Phone: 407-307-6786
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Toolkits to help providers deliver Diabetes Coaching to adolescents with Type 1 diabetes
This study tests whether groups of implementation tools can help pediatric diabetes and psychology teams at a Delaware hospital deliver Diabetes Coaching to more families.
-
Lidocaine During Surgery to See If It Lowers Opioid Use in Kids with Arm Fractures
In children aged 3–18 having surgery for upper-extremity fractures, this study tests whether giving IV lidocaine during the operation reduces the amount of opioid pain medicine needed after surgery.
-
Ultrasound to find elbow fractures in children
This trial tests whether using bedside ultrasound instead of X-rays helps children who come to the ER with elbow pain.
-
GLP-1 medication effects on reproductive hormones in obese teenage girls with PCOS
We will test whether GLP-1 medications are linked to changes in reproductive hormones and menstrual cycles in obese adolescent girls with PCOS.
-
Auryzon EAR 2.0 to shape cartilage for ear reconstruction
This test will try the Auryzon EAR 2.0 device to shape rib cartilage and help surgeons build anatomically accurate ears for children and young adults (ages 5–20) with microtia or other ear deformities.
-
Understanding how genetics affect bronchodilator response in children with bronchiolitis
This study is testing how genetics might affect how well bronchodilator treatments work for young children with bronchiolitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.