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Clinical Trials/NCT07273266
NCT07273266RecruitingNot Applicable

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

Acibadem University2 sites in 1 country62 target enrollmentStarted: March 4, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
62
Locations
2
Primary Endpoint
Feeding maturity

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
0 Days to 28 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

  • Change in Body Weight(From initiation of total oral feeding to hospital discharge (average 5 weeks))
  • Length of Hospital Stay(From baseline to discharge (average 15 weeks))
  • Age at discharge(At first discharge home, on average 37 weeks postmenstrual age)

Investigators

Sponsor
Acibadem University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zehra Kan Onturk

Assoc. Prof.

Acibadem University

Study Sites (2)

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