Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07273266

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acıbadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

Location status: Recruiting

Location contact

Serdar Beken, Prof.

CONTACT

[email protected]

02165004023

Serdar Beken, Prof.

PRINCIPAL_INVESTIGATOR

Zehra Kan Öntürk, Assoc. Prof.

CONTACT

[email protected]

02165004163

Zehra Kan Öntürk, Assoc. Prof.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine NNS

Device

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.

Random NNS

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Length of Hospital Stay

    Time frame: From baseline to discharge (average 15 weeks)

    The time from date of hospitalization until the date of discharge.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zehra Kan Öntürk, Assoc.Prof.

CONTACT

[email protected]

0265004163

Zehra Kan Öntürk, Assoc.Prof.

CONTACT

[email protected]

02165004163

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.