Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT03591835
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2018-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endotracheal Tube Placement in Neonatal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The radiologist who will determine endotracheal tube placement in the X-ray'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-10', 'studyFirstSubmitDate': '2018-06-22', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correct placement of the ETT', 'timeFrame': 'Up to 1 hour', 'description': 'After intubation a portable chest radiograph with digitalized measurements will be obtained to document ETT position. Head at the time of the radiograph will be stabilized in the neutral position. Chest X-ray will be evaluated blindly by a single radiologist in the digital environment (above upper border of T1, in place and below lower border of T2).'}], 'secondaryOutcomes': [{'measure': 'Pneumothorax', 'timeFrame': 'Up to postmenstrual 52 weeks or till discharge', 'description': 'Pneumothorax by transillumination confirmed by chest x-ray.'}, {'measure': 'Bronchopulmonary displasia (BPD)', 'timeFrame': 'Postnatal age of 28 days or till discharge', 'description': 'BPD will be defined according to National Institutes of Health criteria.'}, {'measure': 'Mortality', 'timeFrame': 'Up to postmenstrual 52 weeks or till discharge', 'description': 'We will record who died until discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasal septum-tragus length; newborn'], 'conditions': ['Neonatal Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Endotracheal intubation is a frequent procedure performed in neonates with respiratory distress. Clinicians use different methods to estimate the intubation insertion depth.\n\nIn this study, the investigators aimed to compare the two different methods (kilogram + 6 cm and nasal septum-tragus length (NTL) + 1 cm) used to determine the endotracheal intubation insertion depth.', 'detailedDescription': 'Endotracheal intubation is a frequent procedure performed in neonates with respiratory distress. The ideal location of the tube is between the top of the 1st thoracic vertebra and the bottom of the 2nd thoracic vertebra in the X-ray. Clinicians use different methods to estimate the intubation insertion depth.\n\nIn this study, investigators aimed to compare the two different methods (kilogram+6 cm and nasal septum-tragus length (NTL)+ 1 cm) used to determine the endotracheal intubation insertion depth.\n\nIn this multicentre randomized prospective study, infants who had intubation indications in neonatal intensive care unit will be enrolled. The intubation tube will be fixed at the lip level using the Tochen formula (Group 1) or the NTL+1 cm formula (Group 2). The same brand endotracheal tubes will be used and after intubation the chest radiograph will be performed in the neutral position. Chest X-ray will be evaluated blindly by a single radiologist in the digital environment (above T1, in place and below T2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:.\n\n* Infants who had intubation indications (cardiopulmonary failure, respiratory distress or surfactant administration) in the neonatal intensive care unit\n\nExclusion Criteria:\n\n* Craniofacial, vertebral and genetic anomalies\n* Those whose parents decline consent'}, 'identificationModule': {'nctId': 'NCT03591835', 'briefTitle': 'Endotracheal Tube Placement in Neonatal Intubation', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'Is Nasal Septum-tragus Length Safe in Neonatal Endotracheal Intubation?', 'orgStudyIdInfo': {'id': 'TEP2018133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Weight+6', 'description': "For the Tochen formula in Group 1, ETT depth will be calculated by taking the infant's actual weight within the last 24 h and adding 6 cm.", 'interventionNames': ['Other: Weight+6']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NTL+1', 'description': 'The infants in Group 2 will be intubated by measuring the NTL, the distance from the basement of the nasal septum to the the tragus of the ear.', 'interventionNames': ['Other: NTL+1']}], 'interventions': [{'name': 'Weight+6', 'type': 'OTHER', 'description': "For the Tochen formula in Group 1, ETT depth will be calculated by taking the infant's actual weight within the last 24 h and adding 6 cm.", 'armGroupLabels': ['Weight+6']}, {'name': 'NTL+1', 'type': 'OTHER', 'description': 'The infants in Group 2 will be intubated by measuring the NTL, the distance from the basement of the nasal septum to the the tragus of the ear. Measurements will be recorded as centimeters.', 'armGroupLabels': ['NTL+1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06320', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Zekai Tahir Burak Maternity Teaching Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Diyarbakır', 'country': 'Turkey (Türkiye)', 'facility': 'Diyarbakır Gazi Yaşargil Training and Research Hospital', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Tepecik Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Sanliurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Şanlıurfa Training and Research Hospital', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}], 'overallOfficials': [{'name': 'Mehmet Yekta Oncel, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor, M.D.', 'investigatorFullName': 'Mehmet Yekta', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}