Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
Study NCT ID:
NCT06758492
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-12-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '600 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful thin catheter insertion at the first attempt without physiologic instability', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Successful thin catheter insertion at the first attempt without fall in SpO2 \\>20% from baseline or HR\\<100bpm'}], 'secondaryOutcomes': [{'measure': 'Successful thin catheter insertion at the first attempt', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Successful thin catheter insertion at the first attempt'}, {'measure': 'Physiologic instability during first thin endotracheal catheter insertion attempt', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Fall in SpO2\\>20% from baseline or HR\\<100bpm during first thin endotracheal catheter insertion attempt'}, {'measure': 'Duration of laryngoscopy of first insertion attempt', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Interval from introduction of laryngoscopy blade to its removal (seconds)'}, {'measure': 'Number of attempts taken to insert thin endotracheal catheter', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Number of attempts taken to insert thin endotracheal catheter'}, {'measure': 'Time taken to insert thin endotracheal catheter on successful attempt', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Interval from insertion of laryngoscope blade to insertion of thin endotracheal catheter on successful attempt (seconds)'}, {'measure': 'Total laryngoscopy time to successful insertion', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Sum of all intervals from introduction of laryngoscope blade to removal for unsuccessful insertion attempts; plus interval from introduction of blade to catheter insertion for successful attempt in seconds'}, {'measure': 'Lowest oxygen saturation (SpO2) during the procedure', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Lowest oxygen saturation (SpO2) during the procedure'}, {'measure': 'Lowest heart rate (HR) during the procedure', 'timeFrame': 'At 30 minutes from the start of the insertion attempt', 'description': 'Lowest heart rate (HR) during the procedure'}, {'measure': 'Oral trauma', 'timeFrame': 'At 1 hour from the start of the insertion attempt', 'description': 'Oral trauma reported by clinicians'}, {'measure': 'Chest compressions', 'timeFrame': 'At 1 hour from the start of the insertion attempt', 'description': 'Chest compressions'}, {'measure': 'Adrenaline', 'timeFrame': 'At 1 hour from the start of the insertion attempt', 'description': 'Adrenaline'}, {'measure': 'Further thin catheter surfactant treatment', 'timeFrame': 'Within 72 hours of insertion attempt', 'description': 'Further thin catheter surfactant treatment'}, {'measure': 'Endotracheal intubation and ventilation', 'timeFrame': 'Within 72 hours of insertion attempt', 'description': 'Endotracheal intubation and ventilation'}, {'measure': 'Surfactant treatment via endotracheal tube', 'timeFrame': 'Within 72 hours of insertion attempt', 'description': 'Surfactant treatment via endotracheal tube'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant, newborn', 'respiratory distress syndrome', 'surfactant', 'video laryngoscopy'], 'conditions': ['Respiratory Distress Syndrome (Neonatal)', 'Respiratory Distress Syndrome (RDS)', 'Video Laryngoscopy', 'Surfactant']}, 'descriptionModule': {'briefSummary': "Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope.\n\nThe investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.", 'detailedDescription': 'Many newborn infants have breathing difficulty after birth, particularly when they are born prematurely. Many of these infants are supported with nasal continuous positive airway pressure (NCPAP). Some of the infants deteriorate despite treatment with NCPAP and have a thin catheter inserted into their trachea for the administration of surfactant, which is then immediately removed (often referred to as "less-invasive surfactant administration" or LISA). Insertion of a thin catheter is usually performed by doctors who are experienced at intubation (i.e. inserting endotracheal tubes, ETTs). They look directly into the the infants mouth using a standard laryngoscope to identify the opening of the airway (i.e. perform direct laryngoscopy). More recently video laryngoscopes have been developed. These devices display a magnified image of the airway on a screen that can be viewed indirectly by the doctor attempting to insert the ETT or thin catheter, and also by others. A single centre study reported that more infants were successfully intubated at the first attempt when doctors performed indirect video laryngoscopy compared to direct laryngoscopy.\n\nIt is possible to independently verify when a doctor has correctly inserted and ETT, for example by detecting carbon dioxide coming out of the tube or seeing condensation in the tube during exhalation, or by hearing breath sounds by listening to the chest during positive pressure inflations. It is not possible to independently verify whether a doctor has correctly inserted a thin catheter under direct laryngoscopy, by these or other means. The standard (and to date only) way of confirming that a thin catheter has been correctly inserted is to rely on the report of the operator. Video laryngoscopy, in contrast, allows the independent verification of the tip of a thin catheter by one or more people observing the screen.\n\nThe investigators are performing NEU-VODE, a stepped wedge cluster randomised study of the introduction of video laryngoscopy versus direct laryngoscopy for the intubation of newborn infants. Alongside this study, the investigators are performing a study of infants who have a thin endotracheal catheter inserted under video laryngoscopy versus direct laryngoscopy. As it is not possible to measure the outcome of successful insertion of the thin catheter equally in both groups, this is a prospective observational cohort study. The investigators will record information on infants who have a thin catheter inserted into the trachea for the purpose of surfactant administration at centres participating in the NEU-VODE study. The type of laryngoscope used for thin catheter insertion attempts will not be mandated; instead, the investigators will compare the information of groups within the cohort who have their first attempt made using the video laryngoscope to the group who have their first attempt made with direct laryngoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '0 Minutes', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newborn infants (\\<28 days old) who have a thin catheter inserted into their trachea for the purpose of surfactant administration ("less-invasive surfactant administration", LISA)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newborn infants of any sex who are are having a thin catheter inserted into their trachea for the purpose of surfactant administration\n\nExclusion Criteria:\n\n* no parental consent provided to share their data'}, 'identificationModule': {'nctId': 'NCT06758492', 'acronym': 'NEU-VODEtec', 'briefTitle': 'A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants', 'organization': {'class': 'OTHER', 'fullName': 'University College Dublin'}, 'officialTitle': 'A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants', 'orgStudyIdInfo': {'id': 'NEU-VODEtec 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Video laryngoscopy used to insert thin endotracheal catheter', 'description': 'Video laryngoscopy used to insert thin endotracheal catheter', 'interventionNames': ['Device: Video laryngoscopy used to insert thin endotracheal catheter']}, {'label': 'Direct laryngoscopy used to insert thin endotracheal catheter', 'description': 'Direct laryngoscopy used to insert thin endotracheal catheter', 'interventionNames': ['Device: Direct laryngoscopy used to insert thin endotracheal catheter']}], 'interventions': [{'name': 'Video laryngoscopy used to insert thin endotracheal catheter', 'type': 'DEVICE', 'description': 'Video laryngoscopy used to insert thin endotracheal catheter', 'armGroupLabels': ['Video laryngoscopy used to insert thin endotracheal catheter']}, {'name': 'Direct laryngoscopy used to insert thin endotracheal catheter', 'type': 'DEVICE', 'description': 'Direct laryngoscopy used to insert thin endotracheal catheter', 'armGroupLabels': ['Direct laryngoscopy used to insert thin endotracheal catheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rijeka', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Iva Bilić Čače, MD PhD', 'role': 'CONTACT'}], 'facility': 'Clinical Hospital Centre', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Rebeka Ribičić, MD', 'role': 'CONTACT'}], 'facility': 'Clinical Hospital "Holy Spirit"', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Brno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Andrea Stanikova, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Tereza Lamberská, MD PhD', 'role': 'CONTACT'}], 'facility': 'General University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Milena Tušková, MD', 'role': 'CONTACT'}], 'facility': 'Institute for Mother and Child Care', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Kosmas Sarafidis, MD', 'role': 'CONTACT'}], 'facility': 'Aristotle University of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Budapest', 'status': 'NOT_YET_RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Zsuzsanna Nagy, MD', 'role': 'CONTACT'}], 'facility': 'Second Semmelweiss University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Trevisanuto, MD PhD', 'role': 'CONTACT'}], 'facility': 'University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Anne Lee Solevåg, MD PhD', 'role': 'CONTACT'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Gdansk', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Joanna Jassem-Bobowicz, MD', 'role': 'CONTACT'}], 'facility': 'Medical University of Gdańsk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Iwona Chudek Maruniak, MD', 'role': 'CONTACT'}], 'facility': 'Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Tomasz Szczapa, MD PhD', 'role': 'CONTACT'}], 'facility': 'Poznań University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Rzeszów', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Witold Blaz, MD', 'role': 'CONTACT'}], 'facility': 'Provincial Hospital No. 2', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'city': 'Sibiu', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Maria Livia Ognean, MD PhD', 'role': 'CONTACT'}], 'facility': 'Clinical County Emergency Hospital', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Târgu Mureş', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Manuela Curcerea, MD PhD', 'role': 'CONTACT'}], 'facility': 'George Emil Palade University', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raquel Escrig Fernández, MD PhD', 'role': 'CONTACT'}], 'facility': 'University and Polytechnic Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': "Colm P.F. O'Donnell, MB PhD", 'role': 'CONTACT', 'email': 'codonnell@nmh.ie', 'phone': '+35316373100'}, {'name': 'Janneke Dekker, PhD', 'role': 'CONTACT', 'email': 'j.dekker@lumc.nl'}], 'overallOfficials': [{'name': "Colm P.F. O'Donnell, MB PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Maternity Hospital, Dublin, Ireland'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Study publication, for 2 years', 'ipdSharing': 'YES', 'description': 'Data will be shared o consideration of reasonable request to investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Dublin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leiden University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}