Helping preterm babies learn to feed using scheduled pacifier use
The Effect of Routine Versus Random Pacifier Administration Methods on Feeding Maturity in Preterm Infants
NA · Acibadem University · NCT07273266
This study tests whether giving preterm babies a 5-minute pacifier before each feeding versus a 30-minute pacifier at random times helps them develop feeding skills faster and leave the hospital sooner.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Acibadem University (other) |
| Locations | 1 site (Istanbul, Ataşehir) |
| Trial ID | NCT07273266 on ClinicalTrials.gov |
What this trial studies
Preterm infants who are clinically stable and just starting enteral feeds are randomly assigned to one of two non-nutritive sucking (NNS) strategies: routine 5-minute pacifier use immediately before each feeding or a single 30-minute pacifier session at random times. The trial measures feeding maturity and related clinical outcomes including discharge weight, length of hospital stay, and gestational age at discharge. Infants with contraindications, major comorbidities, intubation, or congenital anomalies are excluded. The single-center study is conducted in the NICU at Acıbadem University in Istanbul and applies the assigned pacifier protocol during the transition from tube to oral feeding.
Who should consider this trial
Good fit: Clinically stable preterm infants who are within the first day of starting enteral feeding and who have no contraindication to pacifier use are ideal candidates.
Not a fit: Infants who are intubated, have significant comorbid medical conditions, congenital anomalies, or any contraindication to pacifier use are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, routine brief pacifier use before feeds could speed feeding skill development, improve weight gain, and shorten hospital stays for preterm infants.
How similar studies have performed: Previous research supports that non-nutritive sucking often helps preterm infants transition to full oral feeding and improves sucking organization, but head-to-head comparisons of specific timing and duration protocols are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm * who are clinically stable, and * who are within the first day of initiating enteral feeding. Exclusion Criteria: * Newborns who have a contraindication to pacifier use * have comorbid medical conditions * who are intubated * have congenital anomalies
Where this trial is running
Istanbul, Ataşehir
- Acıbadem University — Istanbul, Ataşehir, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Serdar Beken — Acibadem University
- Study coordinator: Zehra Kan Öntürk, Assoc.Prof.
- Email: zehrakan@gmail.com
- Phone: 0265004163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm, Feeding, Non Nutritive Sucking, preterm, feeding, non nutritive sucking, feeding maturation