Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 9:14 PM
Study NCT ID:
NCT04944108
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of device positioning', 'timeFrame': '10 minutes', 'description': 'Time needed for the correct positioning of the device into the trachea (thin catheter or tracheal tube). In case of failure, total time will be the sum of time of all attempts.'}], 'secondaryOutcomes': [{'measure': 'Success of the procedure at the first attempt', 'timeFrame': '1 minute', 'description': 'It refers at the success of the device positioning during the first attempt'}, {'measure': "Participant's satisfaction", 'timeFrame': '5 minutes', 'description': 'At the end of the procedure, all participants will be required to fill a 5-item questionnaire aimed to assess their perception on the procedure (Likert scale)'}, {'measure': 'Number of attempts to insert the device in the trachea', 'timeFrame': '10 minutes', 'description': 'It refers to the number of attempts to insert the device in the trachea'}, {'measure': 'Correct depth of the device in the trachea', 'timeFrame': '10 minutes', 'description': 'It refers to reaching the correct depth in the trachea as assessed by the external observer using a laryngoscope'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome', 'Preterm Birth', 'Surfactant Deficiency Syndrome Neonatal']}, 'referencesModule': {'references': [{'pmid': '36261132', 'type': 'DERIVED', 'citation': 'Cavallin F, Bua B, Pasta E, Savio F, Villani PE, Trevisanuto D. Device positioning with LISA vs. INSURE: a crossover randomized controlled manikin trial. J Matern Fetal Neonatal Med. 2022 Dec;35(26):10577-10583. doi: 10.1080/14767058.2022.2134774. Epub 2022 Oct 19.'}]}, 'descriptionModule': {'briefSummary': "This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first and the participant's satisfaction.", 'detailedDescription': "Background: Although LISA offers some advantages in ventilation procedure and neonatal outcomes over INSURE, the use of a catheter during LISA may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device. This is likely to aggravate the invasiveness of the procedure, resulting in stressful consequences such as bradycardia, hypoxia and hemodynamic changes.\n\nObjectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction.\n\nMethods: This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first and the participant's satisfaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Level III NICU consultants and residents will be eligible to participate in the study.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study.'}, 'identificationModule': {'nctId': 'NCT04944108', 'briefTitle': 'LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Padova'}, 'officialTitle': 'Does LISA Change the Time of Device Positioning Compared to INSURE in Extremely Low Birth Weight Infants With RDS? A Crossover Randomized Controlled Manikin Trial', 'orgStudyIdInfo': {'id': 'NEOUNIPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surfactant administration with less invasive surfactant administration (LISA) approach', 'description': 'Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter)', 'interventionNames': ['Procedure: LISA approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surfactant administration with intubation (INSURE) approach', 'description': 'Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)', 'interventionNames': ['Procedure: Insure approach']}], 'interventions': [{'name': 'LISA approach', 'type': 'PROCEDURE', 'otherNames': ['INSURE approach'], 'description': 'Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) or the INSURE approach (tracheal tube)', 'armGroupLabels': ['Surfactant administration with less invasive surfactant administration (LISA) approach']}, {'name': 'Insure approach', 'type': 'PROCEDURE', 'description': 'Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)', 'armGroupLabels': ['Surfactant administration with intubation (INSURE) approach']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brescia', 'country': 'Italy', 'facility': 'Poliambulanza Breacia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'University Hospital of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniele Trevisanuto', 'investigatorAffiliation': 'University Hospital Padova'}}}}