Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT03846960
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2019-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013884', 'term': 'Thiosulfate Sulfurtransferase'}], 'ancestors': [{'id': 'D013466', 'term': 'Sulfurtransferases'}, {'id': 'D019885', 'term': 'Sulfur Group Transferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'intervention of a device product being evaluated in a small clinical trial to determine the feasibility of the product'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2019-01-08', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of attempts until surfactant is administrated', 'timeFrame': 'maximal age 3 days.', 'description': 'Number of intubation attempts- higher values represent a worse outcome'}, {'measure': "Assessment of the infants' stability during the procedure - saturation, bradycardia, tachycardia.", 'timeFrame': 'maximal age 3 days.', 'description': "Monitoring the baby during the procedure and assessment of the infants' stability:\n\nhypoxia (Oxygen saturation less than 60% for more than 5 sec), bradycardia (HR less than 60 for more than 5 sec), tachycardia (HR more than 220 for more than 5 sec) bradycardia below 100 bpm and tachycardia above 220 bpm indicate worse outcome"}, {'measure': 'Duration of the entire procedure, form laryngoscope insertion to surfactants administration and Laryngoscope blade out of the mouth.', 'timeFrame': 'maximal age 3 days.', 'description': 'Time measurement of the procedure, sorter time indicate a better outcome'}], 'secondaryOutcomes': [{'measure': 'Need of invasive mechanical ventilation in the next 24 hours.', 'timeFrame': 'maximal age 3 days.', 'description': 'Failure of non-invasive approach and conversion to invasive ventilation to evaluate the efficiency of the procedure'}, {'measure': 'complications reports - one lung surfactant administration, pneumothorax, NEC, IVH, Pulmonary Hemorrhage', 'timeFrame': 'maximal age 3 days.', 'description': 'Documentation of the complication related to the procedure according to the clinical signs and chest x-ray after the procedure'}, {'measure': 'Subjective procedure scale of assessment.', 'timeFrame': 'maximal age 3 days.', 'description': 'Physician subjective assessment to evaluate the feasibility of the procedure- IRB- approved survey aims to assess user experiences with Video Surfactant Administration Laryngoscopy method in NICU. The survey contains five levels- a) Very satisfied b) Somewhat satisfied c) Neither satisfied nor dissatisfied d) Somewhat dissatisfied e) Very dissatisfied'}, {'measure': 'Unexpected pitfalls reports', 'timeFrame': 'maximal age 3 days.', 'description': 'Physician assessment to evaluate eny pitfalls during the procedure'}, {'measure': 'Safety assessment of the procedure (Physician questionnaire)', 'timeFrame': 'maximal age 3 days.', 'description': 'Physician questionnaire- Do you feel VISUAL method is safe for the premature baby?\n\na)Yes b)Maybe c)No'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['video laryngoscope', 'minimally invasive surfactant administration'], 'conditions': ['Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'In this study the investigators intend to assess the feasibility of surfactant administration via a thin catheter using a specially adapted video laryngoscope, with a groove designed to allow insertion of an endovascular catheter without the use of other instruments in the oral cavity (forceps ect.). The laryngoscope is of Peak Medic Ltd, Netania, Israel.', 'detailedDescription': 'A prospective study to assess the safety and efficacy of surfactant administration via thin catheter using a specially adapted VNscope, originally used for endotracheal intubation and adapted for the administration of surfactant without the placement of an endotracheal tube.\n\nOnce neonates present respiratory distress, the adapted scope will be used - clinical and outcome measures will be collected to asses the safety and efficacy of the use'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '30 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\- Premature infants with gestational age 30-36 weeks.\n2. \\- Diagnosis of respiratory distress syndrome\n3. \\- Treatment with antenatal steroids.\n4. \\- Spontaneously breathing with non-invasive positive pressure ventilation.\n5. \\- maximal age 3 days.\n\nExclusion Criteria:\n\n1. \\- Apgar score at 5 min \\< 5\n2. \\- Need for chest compressions or medication upon delivery.\n3. \\- Evident major congenital malformation, metabolic or genetic disorders.\n4. \\- Clinical evidence of sepsis.'}, 'identificationModule': {'nctId': 'NCT03846960', 'acronym': 'VISUAL', 'briefTitle': 'Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Surfactant Administration Via Thin Catheter Using a Specially Adapted Video Laryngoscope - a Prospective Study Assessing the Feasibility of the VISUAL (Video Surfactant Administration Laryngoscopy) Method', 'orgStudyIdInfo': {'id': '0149-18-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preterm infants', 'description': 'A prospective study to assess the safety and efficacy of surfactant administration via thin catheter using a specially adapted VNscope, originally used for endotracheal intubation and adapted for the administration of surfactant without the placement of an endotracheal tube. A feasibility study of 10 preterm infants 30-36 gestational age at birth, that requires surfactant administration for the indication of respiratory distress syndrome, and do not require immediate intubation', 'interventionNames': ['Device: using specially adapted VNscope', 'Drug: surfactant administration']}], 'interventions': [{'name': 'using specially adapted VNscope', 'type': 'DEVICE', 'otherNames': ['VNScope VNS0-000; VNBlade VNB0-000/1'], 'description': 'surfactant administration via thin catheter using a specially adapted VNscope', 'armGroupLabels': ['preterm infants']}, {'name': 'surfactant administration', 'type': 'DRUG', 'otherNames': ['Curosurf - a porcine surfactant routinely used for RDS'], 'description': 'surfactant administration via thin catheter using a specially adapted VNscope', 'armGroupLabels': ['preterm infants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Haemek medical centre', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Gil talmon, dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'haemek medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carmel Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Attending Neonatologist', 'investigatorFullName': 'Gil Talmon', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}