Effect of Kinesio-taping Technique on Oral Feeding in Late Preterm Infants

January 16, 2024 updated by: Nilay Comuk Balci, Ondokuz Mayıs University

Effect of Kinesio-taping Technique on Oral Feeding and Swallowing Functions: An Acoustic Analysis of Swallowing Sound in Late Preterm Infants

Difficulty in feeding among late preterm infants is one of the most significant factors contributing to prolonged hospitalization and re-admissions. By providing support to the sucking and swallowing muscles early in their development, the maturation process can be expedited, allowing for the safe early discharge of preterm infants.

This study aims to investigate the effects of the Kinesio taping technique on feeding muscles and assess feeding and swallowing function in late preterm infants using acoustic analysis of swallowing sounds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Problems such as poor nutrition, weak sucking, lack of suck-swallow-respiration coordination, low weight gain are among the factors increasing the risk of morbidity in late preterm infants. Early support of sucking and swallowing muscles for the development of suck-swallow coordination can shorten the maturation process and provide early discharge of late preterm infants. The aim of this study is to document kinesiotape technique to support sucking and swallowing muscles for treating nutritional problems and for reducing nutrition risks and accelerating maturation. According to power of analysis of this study, 74 infants planned to assign to kinesiotaping group or control group randomly. In kinesiotaping group, infants feeding performance will be evaluated by measuring the amount of milk invested, maximum heart rate, oxygen saturation, speed of milk intake and counting the number of swallow during feeding. Kinesiotape will be applied to masseter and hyoid muscles 24 hours later after the birth of the infant. Infants will be evaluated before kinesiotape application, 3 hour later and 24 hour later after the application.

Study Type

Interventional

Enrollment (Actual)

74

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
    • Atakum
      • Samsun, Atakum, Turkey, 55139
        • Nilay Çömük Balci

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

No

Description

Inclusion Criteria:

  • Infants born in Baskent University Ankara Hospital,
  • age between 34-36.6 weeks

Exclusion Criteria:

  • Infants with multiple kongenital anomaly,
  • hypoxic ischemic encephalopathy,
  • intraventricular and intracranial hemorrhage,
  • necrotizing enterocolitis,
  • tracheoesophageal fistula,
  • diaphragmatic hernia,
  • hydrocephalus,
  • respiratory distress.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
In this group the late preterm infants won't be applied kinesiotaping to suck and swallow muscles.
Experimental: kinesiotape
Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing.
Device: Kinesiotaping
Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of swallows of the baby during feeding
Time Frame: Through study completion, an average of 1 year
digital stethoscope
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Nilay Comuk Balci, Ondokuz Mayıs University

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)

January 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA18/36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If requested, then the investigators could share the IPD

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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