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Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation

Primary Purpose

Preterm Infant

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

kinesiotape application

About this trial

This is an interventional treatment trial for Preterm Infant focused on measuring preterm infants, kinesiotape, ventilation, respiratory muscles

Eligibility Criteria

24 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Baskent University Ankara HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Kinesiotape

Control

Arm Description

Kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants.

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

Outcomes

Primary Outcome Measures

arterial blood gas

Secondary Outcome Measures

Full Information

NCT ID

NCT03660358

First Posted

September 4, 2018

Last Updated

September 7, 2018

Sponsor

Baskent University

1. Study Identification

Unique Protocol Identification Number

NCT03660358

Brief Title

Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation

Official Title

Effect of Kinesiotaping Applications on Diaphragm, Abdomen and Chest Wall in Preterm Infants Undergoing Noninvasive Ventilation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

May 1, 2019 (Anticipated)

Study Completion Date

May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Infant

Keywords

preterm infants, kinesiotape, ventilation, respiratory muscles

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Kinesiotape

Arm Type

Experimental

Arm Description

Kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants.

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

kinesiotape application

Intervention Description

kinesiotape application to diaphragm, chest wall and abdomen in preterm infants.

Primary Outcome Measure Information:

Title

arterial blood gas

Description

arterial blood gas

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Weeks

Maximum Age & Unit of Time

36 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nilay Comuk Balci, Pt, PhD

Phone

+905067115879

nlycmk@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ayse Ecevit, MD

Phone

+905348937200

ayseecevit@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayse Ecevit, MD

Organizational Affiliation

Associate Professor

Official's Role

Study Director

Facility Information:

Facility Name

Baskent University Ankara Hospital

City

Ankara

State/Province

Bahçelievler

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayse Ecevit, MD

Phone

+905348937200

ayseecevit@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation

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