Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-03 @ 4:06 AM
Study NCT ID:
NCT02700893
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001285', 'term': 'Atropine'}, {'id': 'D001279', 'term': 'Atracurium'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral desaturation', 'timeFrame': 'from 1 minute before to 60 minutes after the start of premedication', 'description': 'rScO2 delta \\>20% from the baseline value (before premedication). rScO2 recording measured by INVOS 1500C 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection'}, {'measure': 'FTOE (Fractional Tissue Oxygen Extraction)', 'timeFrame': 'from 1 minute before to 60 minutes after the start of premedication', 'description': 'Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication. FTOE is calculated from rScO2 and pulse oxymetry (SaO2) with the formula FTOE = SaO2 - rScO2/SaO2. Values will be recorded\n\n1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Premedication', 'Endotracheal Intubation', 'Cerebral Hypoperfusion']}, 'referencesModule': {'references': [{'pmid': '30881948', 'type': 'RESULT', 'citation': 'Vedrenne-Cloquet M, Breinig S, Dechartres A, Jung C, Renolleau S, Marchand-Martin L, Durrmeyer X. Cerebral Oxygenation During Neonatal Intubation-Ancillary Study of the Prettineo-Study. Front Pediatr. 2019 Mar 1;7:40. doi: 10.3389/fped.2019.00040. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'https://www.frontiersin.org/articles/10.3389/fped.2019.00040/full', 'label': 'Open access article'}]}, 'descriptionModule': {'briefSummary': 'Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.\n\nPrimary outcome:\n\n* Cerebral desaturation defined by a rScO2 delta \\>20% from the baseline value (before premedication).\n* Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .\n\nHypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Corrected age \\< 45 weeks of gestational age\n* Currently hospitalized in a neonatal intensive care unit\n* Requiring semi-urgent or elective intubation\n* Equipped with a reliable and permeable IV line\n* Parental consent\n\nExclusion Criteria:\n\n* Lack of parental consent\n* Parental refusal\n* Sedative or anesthetic treatment in the previous 24 hours\n* Hemodynamic compromise defined as mean blood pressure\\< corrected GA and/or refill time \\> 3 seconds\n* Upper airway malformation\n* Life-threatening situation requiring immediate intubation\n* Inclusion in another trial not permitting any other participation\n* Impossibility to establish venous access\n* Any contra-indication to any experimental drug\n* Skin lesions or burns of the forehead'}, 'identificationModule': {'nctId': 'NCT02700893', 'briefTitle': 'Cerebral NIRS Profiles During Premedication for Neonatal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Cerebral NIRS Profiles During Premedication for Neonatal Intubation', 'orgStudyIdInfo': {'id': 'PRETTINEO sub-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atropine + propofol', 'description': 'Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants \\< 1000g - Renewable once 2.5 mg/kg for infants \\> 1000G - Possible additional dose of 1 mg/kg', 'interventionNames': ['Drug: atropine+ propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atropine + atracurium + sufentanil', 'description': 'Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants \\< 1000g 0.2 µg/kg for infants \\> 1000g', 'interventionNames': ['Drug: atropine + atracurium + sufentanil']}], 'interventions': [{'name': 'atropine+ propofol', 'type': 'DRUG', 'description': 'Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants \\< 1000g - Renewable once 2.5 mg/kg for infants \\> 1000G - Possible additional dose of 1 mg/kg', 'armGroupLabels': ['Atropine + propofol']}, {'name': 'atropine + atracurium + sufentanil', 'type': 'DRUG', 'description': 'Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants \\< 1000g 0.2 µg/kg for infants \\> 1000g', 'armGroupLabels': ['Atropine + atracurium + sufentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital intercommunal de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital des enfants', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Meryl Vedrenne-Cloquet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHI Créteil'}, {'name': 'Xavier Durrmeyer, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHI Créteil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association Clinique Thérapeutique Infantile du val de Marne', 'class': 'OTHER'}, {'name': 'Centre de Recherche Clinique du CHIC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Xavier Durrmeyer', 'investigatorAffiliation': 'Centre Hospitalier Intercommunal Creteil'}}}}