The Effect of Routine and Random Pacifier Use Methods in Preterm Infants

January 30, 2024 updated by: Zehra Kan Onturk, Acibadem University

The Effect of Routine and Random Pacifier Use Methods in Preterm Infants on Transition to Bottle Feeding Process

The aim of this study is to determine the effect of the routine 5-min pacifier use before feeding and the random 30-min pacifier use independent from feeding during the day on the transition to bottle feeding process in preterm infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preterm infants, may most frequently experience feeding difficulties as a result of lower oral-motor tone, poor coordination during sucking-swallowing-respiration, sleepy behavior, gastrointestinal dysmotility and immature sucking pressure and being unable to sustain their physiological values at a normal level during feeding. In the literature, it is reported that approximately 82% of preterm infants have an oral feeding difficulty. As a consequence, it is a very complex process to acquire a safe and effective feeding skill and preterm infants need support in the weeks after birth until participants develop skills that are necessary for oral feeding and complete a successful transition to total oral feeding independent from orogastric catheter.

Although studies have stressed positive effects of the Non-nutritive sucking (NNS) intervention on feeding performance, it is reported that there is a need for more comprehensive randomized controlled studies revealing the use frequency, duration or effect of time.

In the Neonatal Intensive Care Unit (NICU) where the study will be conducted, an appropriate method is chosen for preterm infants based on their general condition and the feeding transition stages are determined incrementally with repetitive follow-ups during feeding. The routine 5-min pacifier use method before feeding and the random 30-min pacifier use method during the day will be applied to newborns who have enteral feeding. Newborns who already use pacifier independent from feeding during the day in the clinic and to whom these methods are applied, will comprise the control group. In order to ensure a homogeneous application in the control group, the pacifier use duration will be limited to 30 minutes. Pacifier use durations have been determined in line with the literature examining the contribution of pacifier use to the feeding of preterm infants. Newborns, to whom the routine 5-min pacifier use method is applied before each feeding, will comprise the experimental group. All newborns included in the study will be followed until participants are discharged.

Study Type

Interventional

Enrollment (Actual)

43

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Acıbadem University Atakent Hospital

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

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Preterm infants;

  • Whose legal representatives agree to take part in the study and sign the informed consent form,
  • Who have a stable clinical picture,
  • Who are on the first day of enteral feeding will be included in the study.

Exclusion Criteria:

Preterm infants;

  • Who have a comorbidity,
  • Who are intubated,
  • Who have an inherent anomaly,
  • Who have parenteral feeding will not be included in the study.

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: Control group (Pacifier randomly 30 min)
Pacifier is randomly given to the infant for 30 min independent from feeding during the day
Procedure: Pacifier randomly

Common Action Steps:

  1. Legal representatives of newborns are informed about the study purpose, participants read and sign the informed consent form so their consent is obtained.
  2. Inclusion and exclusion criteria are evaluated.
  3. Study group is determined in line with the randomization order of the newborn to be included in the study.
  4. First part of the patient information and follow-up form is completed.
  5. Feeding content, amount and method are determined by the physician.

Action Steps of the Control Group:

* Pacifier is randomly given to the infant for 30 min independent from feeding during the day.

  1. Common procedure steps are applied.
  2. Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method.
  3. Second part of the patient information and follow-up form is completed daily.
Experimental: Experimental Group (Pacifier randomly 30 min+ routine 5 min before each feeding)
Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding.
Procedure: Pacifier other

Procedure Steps of the Experimental Group:

  • Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding.

    1. Common procedure steps are applied.
    2. Pacifier is given for 5 min before each feeding.
    3. Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method.
    4. Second part of the patient information and follow-up form is completed daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in feed intake
Time Frame: From baseline to transition to total oral feeding (average 15 weeks)
Change in feed intake will be assessed from baseline to transition to total oral feeding
From baseline to transition to total oral feeding (average 15 weeks)
Change in body weight
Time Frame: From baseline to transition to total oral feeding (average15 weeks)
Participant's body weight will be assessed from baseline to transition to total oral feeding up to through study completion
From baseline to transition to total oral feeding (average15 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)

Collaborators and Investigators

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

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Zehra Kan Öntürk, Assist Prof, 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)

May 2, 2021

Primary Completion (Actual)

May 22, 2023

Study Completion (Actual)

May 22, 2023

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2021/08

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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