Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-28 @ 2:50 AM
Study NCT ID:
NCT05024435
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2021-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], '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': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful intratracheal tube Placement', 'timeFrame': 'Birth to 24 hours after birth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Less Invasive Surfactant Administration', 'Minimal Invasive Surfactant Treatment', 'Preterm Infant', 'Respiratory Distress Syndrome', 'Surfactant'], 'conditions': ['Neonatology', 'Perinatal Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '36333741', 'type': 'DERIVED', 'citation': 'Auer-Hackenberg L, Brandner J, Hofstatter E, Stroicz P, Hager T, Eichhorn A, Schutz S, Feldner R, Wald M. A pilot study of evaluation of semi-rigid and flexible catheters for less invasive surfactant administration in preterm infants with respiratory distress syndrome-a randomized controlled trial. BMC Pediatr. 2022 Nov 4;22(1):637. doi: 10.1186/s12887-022-03714-3.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.', 'detailedDescription': 'In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomised to two different modes of endotracheal catheterization: Flexible Ch-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate and vital parameters during laryngoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants born less than 37 weeks of gestation\n* Treating physician in charge of admission decides to administer intratracheal surfactant via standardized institution- LISA protocol (regardless of this study) (see Supplement file 1)\n* Written informed consent signed by caregivers or legal representative to participate\n\nExclusion Criteria:\n\n* Refusal to participate in study or not providing written informed consent by caregivers/parents\n* Treating physician decides to use different route of surfactant administration or does not adhere to LISA protocol.\n* Rupture of membranes (ROM) at less than 22 weeks of gestation or more than 6 weeks before birth\n* Estimated birth weight \\< 3rd percentile using 2013 Fenton growth trajectories\n* Twins with feto-fetal transfusion syndrome (FFTS) and FFTS being the cause of premature delivery\n* Contraindications listed in the LISAcath® or Nasogastric Tube manual (esophageal/pharyngeal varices or other vascular lesions, esophageal/pharyngeal tumor, nasal fracture, skull fracture, known allergy to material)'}, 'identificationModule': {'nctId': 'NCT05024435', 'briefTitle': 'Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Salzburger Landeskliniken'}, 'officialTitle': 'Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '415-E/2532/7-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasogastric Tube', 'interventionNames': ['Device: Surfactant Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Lisacath', 'interventionNames': ['Device: Surfactant Administration']}], 'interventions': [{'name': 'Surfactant Administration', 'type': 'DEVICE', 'description': 'Laryngoscopy, intratracheal catheter placement and surfactant administration', 'armGroupLabels': ['Lisacath', 'Nasogastric Tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Salzburger Landeskliniken', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Martin Wald, MD, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salzburger Landeskliniken', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, University Hospital Salzburg, Department of Pediatrics and Adolescent Medicine, Physician Division of Neonatology', 'investigatorFullName': 'Lorenz Auer-Hackenberg', 'investigatorAffiliation': 'Salzburger Landeskliniken'}}}}