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Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03660358
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : September 10, 2018
Information provided by (Responsible Party):
Nilay Comuk Balci, Baskent University

Brief Summary:
Kinesiotaping (KT) applied to the thorax is believed to enhance breathing by supporting the respiratory muscles. Infants born premature usually have respiratory problems because of depletion of surfactant and respiratory muscle weakness. Therefore, we are going to use KT for premature infants in NICU who are undergoing non-invasive ventilation. Forty-two participants divided into two groups. The first group will be applied KT to chest wall, abdomen and diaphragm, and the other group will not receive any KT application during non-invasive ventilation. KT application will be going on as long as the infant underwent non-invasive ventilation. We are going to measure blood gas parameters (pH, pCO2, pO2, base excess), respiration rate, peak heart rate, percentage of Fio2, FiO2/pO2 rate, PEEP and PIP values before non-invasive ventilation, 2 hours after non-invasive ventilation, within 72 hours and shortly before weaning from non-invasive ventilation.

Condition or disease Intervention/treatment Phase
Preterm Infant Device: kinesiotape application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Kinesiotaping Applications on Diaphragm, Abdomen and Chest Wall in Preterm Infants Undergoing Noninvasive Ventilation
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Arm Intervention/treatment
Experimental: Kinesiotape
Kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants.
Device: kinesiotape application
kinesiotape application to diaphragm, chest wall and abdomen in preterm infants.

No Intervention: Control
No kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants.

Primary Outcome Measures :
  1. arterial blood gas [ Time Frame: 1 day ]
    arterial blood gas

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Inpatient infants in NICU, born in Baskent University Ankara Hospital, undergoing non-invasive ventilation and age between 24-36.6 weeks.

Exclusion Criteria:

  • Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, tracheoesophageal fistula, diaphragmatic hernia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03660358

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Contact: Nilay Comuk Balci, Pt, PhD +905067115879
Contact: Ayse Ecevit, MD +905348937200

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Baskent University Ankara Hospital Recruiting
Ankara, Bahçelievler, Turkey
Contact: Ayse Ecevit, MD    +905348937200   
Sponsors and Collaborators
Baskent University
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Study Director: Ayse Ecevit, MD Associate Professor

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Responsible Party: Nilay Comuk Balci, Associate Professor, Baskent University Identifier: NCT03660358     History of Changes
Other Study ID Numbers: KA18/35
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nilay Comuk Balci, Baskent University:
preterm infants
respiratory muscles

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications