Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants.
Jann P Foster, Kim Psaila, Tiffany Patterson
https://pubmed.ncbi.nlm.nih.gov/27699765Actively Recruiting
Phase Not Applicable
Age: 0Days - 28Days
All Genders
Healthy Volunteers
ID07273266
The Effect of Routine Versus Random Pacifier Use Methods on Feeding Maturity in Preterm Infants
Led by Acibadem University · Updated on 2025-12-09
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different pacifier-use strategies on feeding maturity in preterm infants. The study aims to compare routine 5-minute pacifier use before each feeding with random 30-minute pacifier use at any time of day, regardless of feeding. The purpose is to understand how these methods influence feeding development, discharge weight, hospital stay length, and gestational age at discharge in these infants. The trial has two groups: one where newborns receive a pacifier for 5 minutes before each feeding (routine group) and another where newborns receive a pacifier for 30 minutes at random times based on infant cues (control group). Feeding methods and amounts are determined by physicians following newborn nursing protocols. Feeding maturity will be assessed weekly using a feeding monitor throughout the study. Participants will be monitored from the start of oral feeding until hospital discharge, with weekly assessments for up to 6 weeks. Researchers will measure changes in feeding maturity, body weight from total oral feeding initiation to discharge, length of hospital stay, and gestational age at discharge. The average observation periods include about 5 weeks for weight change and 15 weeks for hospital stay, with discharge occurring around 37 weeks postmenstrual age.
CONDITIONS
Brief Title
Feeding Maturity in Preterm Infants
Who Can Participate
Age: 0Days - 28Days
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Preterm infant
- Clinically stable condition
- Within the first day of starting enteral feeding
You will not qualify if you...
- Newborns with contraindications to pacifier use
- Presence of comorbid medical conditions
- Infants who are intubated
- Newborns with congenital anomalies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - From the start of oral feeding until hospital discharge, up to 6 weeks
Participants receive pacifier use following one of two schedules: routine 5-minute use before each feeding or random 30-minute use at times independent of feeding. Feeding maturity is assessed weekly during this period.
Weekly visits for feeding maturity assessment
Trial Site Locations
Total: 1 location
1
Acıbadem University
Istanbul, Ataşehir, Turkey (Türkiye), 34750
Actively Recruiting
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Research Team
Z
Zehra Kan Öntürk, Assoc.Prof.
Z
Zehra Kan Öntürk, Assoc.Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants: a randomised controlled trial.
Vildan Kaya, Aynur Aytekin
https://pubmed.ncbi.nlm.nih.gov/27754572Determination of oral feeding skills in late preterm, early term, and full-term infants using the neonatal oral feeding monitor (NeoSAFE).
Ayse Ecevit, Balkar Erdogan, Deniz Anuk Ince...
https://pubmed.ncbi.nlm.nih.gov/39920842Effects of an Oral Stimulation Program on Feeding Outcomes in Preterm Infants: A Systematic Review and Meta-Analysis.
Elena Muñoz-Gómez, Marta Inglés, Sara Mollà-Casanova...
https://pubmed.ncbi.nlm.nih.gov/37203152Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis.
Shuliang Zhao, Huimin Jiang, Yiqun Miao...
https://pubmed.ncbi.nlm.nih.gov/38626172