Preterm InfantNCT03660358
Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation
A study testing kinesiotape application in people with Preterm Infant, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 36 weeks
- Conditions the study is for
- Preterm Infant
- What is being tested?
- kinesiotape application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inpatient infants in NICU, born in Baskent University Ankara Hospital, undergoing non-invasive ventilation and age between 24-36.6 weeks.
Who cannot join
- Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, tracheoesophageal fistula, diaphragmatic hernia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University Ankara Hospital
Ankara, Bahçelievler
Ayse Ecevit, MD, +905348937200, ayseecevit@yahoo.com
About this study
Official title: Effect of Kinesiotaping Applications on Diaphragm, Abdomen and Chest Wall in Preterm Infants Undergoing Noninvasive Ventilation
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.
- Conditions
- Preterm Infant
- Being tested
- kinesiotape application
- Keywords
- preterm infants, kinesiotape, ventilation, respiratory muscles
- Medical subject headings
- Premature Birth, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotape applicationDevice
kinesiotape application to diaphragm, chest wall and abdomen in preterm infants.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape | Experimental | Kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants. Receives: Device: kinesiotape application |
| Control | No intervention | No kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood gas
arterial blood gas
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 May 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Comuk Balci, Baskent University
- Investigators
- Ayse Ecevit, MD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660358
- Sponsor's protocol ID
- KA18/35
- Status last verified
- Sep 2018
- First submitted
- 4 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesiotaping Applications on Diaphragm, Abdomen and Chest Wall in Preterm Infants Undergoing Noninvasive Ventilation
- ClinicalTrials.gov ID
- NCT03660358
- Acronym / sponsor ID
- KA18/35
- Conditions
- Preterm Infant
- Keywords
- preterm infants, kinesiotape, ventilation, respiratory muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape | Experimental | Device: kinesiotape applicationKinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants. |
| Control | No intervention | –No kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants. |
Who may qualify
- Ages
- 24 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inpatient infants in NICU, born in Baskent University Ankara Hospital, undergoing non-invasive ventilation and age between 24-36.6 weeks.
Key exclusion criteria (1 listed)
- Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, tracheoesophageal fistula, diaphragmatic hernia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kinesiotape applicationkinesiotape application to diaphragm, chest wall and abdomen in preterm infants. | Device | Kinesiotape |
Primary outcome
arterial blood gas
Time frame: 1 day
arterial blood gas
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Preterm Infant
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Ecevit, MD study director
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesiotape application in people with Preterm Infant, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilay Comuk Balci, Pt, PhD (+905067115879, nlycmk@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood gas (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.