Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-28 @ 4:03 PM
Study NCT ID:
NCT06285669
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], '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': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Kinesio-Taping Application'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of pH', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory distress syndrome', 'preterm infant', 'kinesiotaping', 'pulmonary function'], 'conditions': ['Preterm', 'Premature', 'Infant, Newborn, Diseases', 'Respiratory Distress Syndrome', 'Neonatal Respiratory Distress']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the effects of kinesio taping on blood gas parameters, respiratory rate, heart rate, oxygen saturation, and pressure limits in preterm infants with RDS who are on NIV. It is hypothesized that the application of kinesio taping to the chest area of preterm infants may improve respiratory functions and oxygenation at the alveolar level, leading to decreased work of breathing, reduced respiratory rate, and improved neonatal stability by promoting respiratory mechanics and enhancing chest expansion.', 'detailedDescription': 'Very preterm infants are at high risk of respiratory distress syndrome (RDS), due to surfactant deficiency and weak respiratory muscles. This condition can contribute to respiratory workload and irregular breathing. This study aimed to investigate the effects of Kinesio kinesio-taping technique on the respiratory muscles and diaphragm in very preterm infants undergoing non-invasive.\n\nTwenty-six preterm infants born before the 32nd gestational week and requiring non-invasive ventilation (NIV) support due to RDS, were randomly divided into 2 groups as Kinesio taping group and control group. Kinesio taping was applied by a single physiotherapist to support the intercostal muscles,and, the diaphragm and facilitatory method was used on the respiratory muscles. Kinesio taping was removed just after preterm infants were weaned from noninvasive ventilation. Blood gas parameters, respiratory rate, heart rate, FiO2, FiO2/pO2 ratio, PIP, PEEP values, and length of stay in NIV were recorded before and after 3 days of KT application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants diagnosed with RDS\n* Preterm Infants born under 32 weeks of gestation\n\nExclusion Criteria:\n\n* Sepsis,\n* necrotizing enterocolitis,\n* metabolic disease,\n* severe congenital malformations of the chest and abdominal walls,\n* congenital heart disease,\n* major congenital anomalies'}, 'identificationModule': {'nctId': 'NCT06285669', 'briefTitle': 'Effects of Kinesiotaping on Respiratory Muscles in Very Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Effects of Kinesio Taping Applications on Diaphragm, Respiratory Muscles and Chest Wall In Very Preterm Infants On Non-invasive Ventilation', 'orgStudyIdInfo': {'id': 'KA18/35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'kinesiotape', 'description': 'Kinesio taping was applied by a single physiotherapist to support the intercostal muscles,and, the diaphragm and facilitatory method was used on the respiratory muscles', 'interventionNames': ['Other: kinesiotaping application']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "This group didn't take kinesiotape application"}], 'interventions': [{'name': 'kinesiotaping application', 'type': 'OTHER', 'description': 'kinesiotaping application', 'armGroupLabels': ['kinesiotape']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55139', 'city': 'Samsun', 'state': 'Atakum', 'country': 'Turkey (Türkiye)', 'facility': 'Nilay Çömük Balci', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Nilay Comuk Balci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Proffessor', 'investigatorFullName': 'Nilay Comuk Balci', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}