Feeding Maturity in Preterm Infants

December 7, 2025 updated by: Zehra Kan Onturk, Acibadem University

The Effect of Routine Versus Random Pacifier Administration Methods on Feeding Maturity in Preterm Infants

The aim of this study is to evaluate the effect of two pacifier-use strategies-routine 5-minute pacifier use prior to each feeding versus random 30-minute pacifier use at any time of day, independent of feeding-on feeding maturity in preterm infants. The hypotheses of the study are as follows: H1: The routine use of a pacifier prior to feeding has a positive effect on feeding maturity in preterm infants.

H2: The routine use of a pacifier prior to feeding has a positive effect on discharge weight in preterm infants.

H3: The routine use of a pacifier prior to feeding has a positive effect on the length of hospital stay in preterm infants.

H4: The routine use of a pacifier prior to feeding has a positive effect on the gestational age at discharge in preterm infants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Developing safe and effective feeding skills in preterm infants is a highly complex process. To achieve feeding maturity, preterm infants must establish oropharyngeal anatomical integrity, adequate neurological function, and full coordination of sucking, swallowing, and breathing. Due to this immaturity, they frequently experience oral feeding difficulties such as low oral-motor tone, poor suck-swallow-breath coordination, sleepiness, gastrointestinal dysmotility, immature sucking pressure, and an inability to maintain stable physiological parameters during feeding. Effective oral feeding is crucial for optimal growth, safe discharge, and the prevention of aspiration and long-term respiratory or neurological complications.

For this reason, preterm infants require support until they develop the necessary skills for oral feeding and successfully transition from orogastric tube feeding to total oral intake. During this transition period, early oral stimulation methods help promote oral development and self-regulation. Among these supportive and complementary strategies, non-nutritive sucking (NNS) facilitates the progression toward oral feeding. Evidence indicates that infants who receive NNS transition to full oral feeding more quickly, demonstrate better feeding performance, achieve more organized sucking behavior, experience improved digestion, and remain more active during feeds.

Although studies emphasize the benefits of NNS, research examining how the frequency, duration, or timing of NNS influences feeding maturity remains limited.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zehra Kan Öntürk, Assoc.Prof.
  • Phone Number: 0265004163
  • Email: zehrakan@gmail.com

Study Contact Backup

  • Name: Zehra Kan Öntürk, Assoc.Prof.
  • Phone Number: 02165004163
  • Email: zehrakan@gmail.com

Study Locations

  • Turkey (Türkiye)
    • Ataşehir
      • Istanbul, Ataşehir, Turkey (Türkiye), 34750
        • Recruiting
        • Acıbadem University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Zehra Kan Öntürk, Assoc. Prof.
        • Principal Investigator:
          • Serdar Beken, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Routine NNS
Newborns who receive routine 5-minute pacifier use before each feeding will constitute the intervention group.
Device: Routine NNS

The content, volume, and method of feeding are determined by the physician. A pacifier is provided for 5 minutes before each feeding. Procedures are carried out in accordance with the "Newborn Nursing Protocols," based on the infant's feeding method.

Feeding maturity is assessed once a week using a feeding monitor.
Other: Control group (Random NNS)
Newborns who are given a pacifier for 30 minutes at random times throughout the day, independent of feeding and based on the infant's cues, will constitute the control group.
Device: Random NNS

The content, volume, and method of feeding are determined by the physician. The infant is given a pacifier for 30 minutes at random times during the day, independent of feeding.

Procedures are carried out in accordance with the "Newborn Nursing Protocols," based on the infant's feeding method.

Feeding maturity is assessed once a week using a feeding monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding maturity
Time Frame: From the start of oral feeding until hospital discharge; assessed weekly for up to 6 weeks. The change in these time intervals will be assessed.
Feeding maturity will be evaluated using a feeding monitor, assessing key swallowing and respiratory coordination parameters, including the number and duration of rhythmic swallows, rest periods, swallow-respiration patterns, and total milk volume consumed.
From the start of oral feeding until hospital discharge; assessed weekly for up to 6 weeks. The change in these time intervals will be assessed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: From initiation of total oral feeding to hospital discharge (average 5 weeks)
Participant's body weight will be assessed at initiation of total oral feeding and at hospital discharge.
From initiation of total oral feeding to hospital discharge (average 5 weeks)
Length of Hospital Stay
Time Frame: From baseline to discharge (average 15 weeks)
The time from date of hospitalization until the date of discharge.
From baseline to discharge (average 15 weeks)
Age at discharge
Time Frame: At first discharge home, on average 37 weeks postmenstrual age
Postmenstrual age (weeks) of the infant at the time of hospital discharge.
At first discharge home, on average 37 weeks postmenstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Serdar Beken, Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2024/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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