Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-20 @ 4:29 PM
Study NCT ID:
NCT03660358
Status:
UNKNOWN
Last Update Posted:
2018-09-10
First Post:
2018-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2018-09-04', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial blood gas', 'timeFrame': '1 day', 'description': 'arterial blood gas'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm infants', 'kinesiotape', 'ventilation', 'respiratory muscles'], 'conditions': ['Preterm Infant']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '24 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatient infants in NICU, born in Baskent University Ankara Hospital, undergoing non-invasive ventilation and age between 24-36.6 weeks.\n\nExclusion Criteria:\n\n* Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, tracheoesophageal fistula, diaphragmatic hernia.'}, 'identificationModule': {'nctId': 'NCT03660358', 'briefTitle': 'Effect of Kinesiotaping Application in Preterm Infants Undergoing Noninvasive Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'Effect of Kinesiotaping Applications on Diaphragm, Abdomen and Chest Wall in Preterm Infants Undergoing Noninvasive Ventilation', 'orgStudyIdInfo': {'id': 'KA18/35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinesiotape', 'description': 'Kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants.', 'interventionNames': ['Device: kinesiotape application']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No kinesiotaping aplication to chest wall, abdomen and diaphragm in preterm infants.'}], 'interventions': [{'name': 'kinesiotape application', 'type': 'DEVICE', 'description': 'kinesiotape application to diaphragm, chest wall and abdomen in preterm infants.', 'armGroupLabels': ['Kinesiotape']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Bahçelievler', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ayse Ecevit, MD', 'role': 'CONTACT', 'email': 'ayseecevit@yahoo.com', 'phone': '+905348937200'}], 'facility': 'Baskent University Ankara Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Nilay Comuk Balci, Pt, PhD', 'role': 'CONTACT', 'email': 'nlycmk@yahoo.com', 'phone': '+905067115879'}, {'name': 'Ayse Ecevit, MD', 'role': 'CONTACT', 'email': 'ayseecevit@yahoo.com', 'phone': '+905348937200'}], 'overallOfficials': [{'name': 'Ayse Ecevit, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nilay Comuk Balci', 'investigatorAffiliation': 'Baskent University'}}}}