NCT03660358

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 4, 2018

Last Update Submit

September 7, 2018

Conditions

Keywords

preterm infantskinesiotapeventilationrespiratory muscles

Outcome Measures

Primary Outcomes (1)

  • arterial blood gas

    arterial blood gas

    1 day

Study Arms (2)

Kinesiotape

EXPERIMENTAL

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

Device: kinesiotape application

Control

NO INTERVENTION

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

Interventions

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

Kinesiotape

Eligibility Criteria

Age24 Weeks - 36 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Bahçelievler, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature BirthRespiratory Aspiration

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ayse Ecevit, MD

    Associate Professor

    STUDY DIRECTOR

Central Study Contacts

Nilay Comuk Balci, Pt, PhD

CONTACT

Ayse Ecevit, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

September 10, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations