Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-30 @ 5:17 PM
Study NCT ID:
NCT00797160
Status:
UNKNOWN
Last Update Posted:
2008-11-25
First Post:
2008-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-07-22', 'releaseDate': '2011-06-27'}, {'releaseDate': '2014-07-24', 'unreleaseDateUnknown': True}, {'releaseDate': '2014-08-03', 'unreleaseDateUnknown': True}, {'releaseDate': '2014-08-05', 'unreleaseDateUnknown': True}], 'estimatedResultsFirstSubmitDate': '2011-06-27'}}, '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': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-11-24', 'studyFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2008-11-24', 'lastUpdatePostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time until extubation after bolus dose as premedication for tracheal intubation', 'timeFrame': 'within the first 3 days of life'}], 'secondaryOutcomes': [{'measure': 'Quality of intubation with the combination of drugs used for premedication', 'timeFrame': 'within the first 2 days of life'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['propofol', 'midazolam', 'neonate', 'tracheal intubation'], 'conditions': ['Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "SILVA,Y.P. et al. Morphine versus remifentanil for intubating preterm neonates. Short report.Archives of Disease in Childhood Fetal & Neonatal Edition;92:4.2007. Dani C, Bertini G, Pezzati M, et al. Early Extubation and Nasal Continuous Positive Airway Pressure After Surfactant Treatment for Respiratory Distress Syndrome Among Preterm Infants <30 Weeks' Gestation. Pediatrics 2004; 113:560-563. Carbajal R, Eble B, Anand KJS. Premedication for Tracheal Intubation in Neonates: Confusion or Controversy? Seminars in Perinatology 2007; 31:309-317. Silva YP, Gomez RS, Marcatto JO, et al. Early awakening and extubation with remifentanil in ventilated premature neonates. Pediatric Anesthesia 2008; 18:176-183. Welzing L, Roth B. Experience with remifentanil in neonates and infants. Drugs 2006; 66(10):1339-1350."}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the intubation conditions among propofol and remifentanil versus midazolam and remifentanil in premature neonates with respiratory distress syndrome. At the same time, to show the group of drugs that could let the neonates with no residual sedation after the use of surfactant (the possibility of the premature neonates to be readily extubated after the use of surfactant).', 'detailedDescription': 'It has been demonstrated that remifentanil, due to it its very short context-sensitive, has an interesting potential for use in premature neonates with respiratory distress syndrome. Indeed, remifentanil allowed an adequate level of sedation and analgesia as well as rapid recovery after discontinuation. The aim of the present study was to compares the intubation conditions among propofol and remifentanil versus midazolam and remifentanil in premature neonates with respiratory distress syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'minimumAge': '30 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age between 28-34 wk\n* Clinical and radiological features compatible with respiratory distress syndrome that required elective tracheal intubation and surfactant therapy\n* Hemodynamic stability before tracheal intubation\n* Signature (parents) consent form\n\nExclusion Criteria:\n\n* The presence of major congenital malformations\n* Birth weigh less than 1000 g\n* Previous use of opioid or other sedative drug for any reason\n* Previous tracheal intubation\n* Hemodynamic instability before the indication of tracheal intubation\n* Refuse of the parents to enroll the neonate in the study protocol'}, 'identificationModule': {'nctId': 'NCT00797160', 'briefTitle': 'Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Propofol and Remifentanil Versus Midazolam and Remifentanil as Premedication Allowing Very Early Extubation After Surfactant Treatment in Preterm Neonates With Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '0011.0.287.000-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'propofol', 'type': 'DRUG', 'description': '2mg/Kg IV in bolus before tracheal intubation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30620470', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Márcia G Penido, MD', 'role': 'CONTACT', 'email': 'mgpenido@gmail.com', 'phone': '00553193047238'}, {'name': 'Márcia G Penido, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neonatology of Julia Kubitschek Hospital', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'centralContacts': [{'name': 'Yerkes P Silva, PhD', 'role': 'CONTACT', 'email': 'yerkesps@uol.com.br', 'phone': '00553199933384'}, {'name': 'Márcia G Penido, MD', 'role': 'CONTACT', 'email': 'mgpenido@gmail.com', 'phone': '00553193047238'}], 'overallOfficials': [{'name': 'Yerkes P Silva, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yerkes Pereira e Silva', 'oldOrganization': 'Federal University of Minas Gerais'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-06-27', 'type': 'RELEASE'}, {'date': '2011-07-22', 'type': 'RESET'}, {'date': '2014-07-24', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2014-08-03', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2014-08-05', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}], 'unpostedResponsibleParty': 'Renato Santiago Gomez, PhD, Federal University of Minas Gerais'}}}}