Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 12:42 PM
Study NCT ID:
NCT03359993
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Umbilical Vein Needle Catheterization for Endotracheal Intubation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-11-28', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conditions of intubation', 'timeFrame': 'Seven months', 'description': "Classified from bad to excellent, depending on the neonates' residual tone, vocal chords mobility, and persistence of movements while inserting the tube."}], 'secondaryOutcomes': [{'measure': 'Duration of intubation', 'timeFrame': 'Seven months', 'description': 'The investigators measure the time in seconds between insertion of the tube and the end of fixation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endotracheal intubation', 'Neonatal premedication', 'Delivery room'], 'conditions': ['Infant Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': "The investigators describe a simple and efficient method to give a premedication in the delivery room, using the umbilical vein, directly punctured through Wharton's jelly.", 'detailedDescription': 'The umbilical vein is punctured to inject drugs efficiently. The access is simple, the umbilical vein is clearly visible, and a blood reflux can be found easily. The investigators used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. The investigators report 5 cases of intubations in the delivery room using this method to administer the premedication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Minutes', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (IRDS)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (IRDS).\n\nExclusion Criteria:\n\n* Refusal of legal owners'}, 'identificationModule': {'nctId': 'NCT03359993', 'acronym': 'Intubation', 'briefTitle': 'Umbilical Vein Needle Catheterization for Endotracheal Intubation.', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital NOVO'}, 'officialTitle': 'Umbilical Vein Needle Catheterization for Endotracheal Intubation.', 'orgStudyIdInfo': {'id': 'CHRD0417'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm infants intubated', 'description': 'All participants were preterm infants intubated in the delivery room for Infantile Respiratory Distress Syndrome (IRDS). The purpose of this research is to determine a premedication of intubation. This consists of describing a simple and effective method for premedication in the delivery room, using the umbilical vein, directly perforated through the Wharton jelly.', 'interventionNames': ['Procedure: Premedication of intubation']}], 'interventions': [{'name': 'Premedication of intubation', 'type': 'PROCEDURE', 'description': 'The umbilical vein is punctured to inject drugs efficiently. The access is simple, the umbilical vein is clearly visible, and a blood reflux can be found easily. We used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. We report 5 cases of intubations in the delivery room using this method to administer the premedication.', 'armGroupLabels': ['Preterm infants intubated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95390', 'city': 'Pontoise', 'country': 'France', 'facility': 'Centre Hospitalier René Dubos', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}], 'overallOfficials': [{'name': 'Suzanne BORRHOMEE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital NOVO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital NOVO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}