{ "FullStudy":{ "Rank":217711, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517828", "OrgStudyIdInfo":{ "OrgStudyId":"UF8736" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-003216-23", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"University Hospital, Montpellier", "OrgClass":"OTHER" }, "BriefTitle":"Intranasal Midazolam Versus Intranasal Ketamine to Sedate Newborns for Intubation in Delivery Room", "OfficialTitle":"Intranasal Midazolam Versus Intranasal Ketamine to Sedate Newborns for Intubation in Delivery Room." }, "StatusModule":{ "StatusVerifiedDate":"December 2014", "OverallStatus":"Unknown status", "LastKnownStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2016", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"May 2016", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"December 12, 2011", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 2, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 3, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"University Hospital, Montpellier", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Anesthesia is rarely used to intubate newborns in delivery room because of the very difficulty of accessing veins. The investigators hypothesized that intranasal administration of sedative would be an effective alternative. -Midazolam and Ketamine are two drugs used during neonates' intubation. They are also used intranasally in the absence of venous access-In a pilot study the investigators have demonstrated that sedation with Midazolam was effective in 67% of the patients. Efficiency was defined by a specific pain score: FANS < 4 (Faceless Acute Neonatal Pain Scale) and by an impedancemetric Pain monitor < 0.2 spike/s.\n\nThe investigators hypothesized that intranasal ketamine would increase procedure effectiveness from 67 to 90%.\n\nMain objective: To compare newborns sedation quality as they are sedated either by intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.\nSecondary Objectives: To compare intubation quality, hemodynamic and respiratory tolerance, and neurological outcomeat 2 years within the two groups.", "DetailedDescription":"Randomized, double blind prospective multicenter study. Patients:-Inclusion criteria: (1) neonates in delivery room (2) Presence of repiratory distress syndrom requiring intubation (Silverman score> 3 and / or FiO2 greater than 30 % in premature infants under 30 weeks and over 40% after 30 weeks (3) hemodynamic stability (mean arterial pressure> 3° percentile)\n\nExclusion criteria: (1) Need for intubation in extreme emergency (pneumothorax, meconium aspiration, congenital diaphragmatic hernia, perinatal asphyxia) (2) Birth in the absence of an independent appraiser (3) mother under general anesthesia.\nNumber of subjects required: 120 patients (60 per group) over a period of two years. This number was calculated to show a difference in sedation effectiveness from 67 to 90% with an alpha risk of 5% and a beta risk of 20%.\nStudy design:\n\nAfter obtaining parental consent, patients will be randomized in \"Midazolam\" arm or in \"Ketamine\" arm . Midazolam (0.2mg/kg = 0.2ml/kg) or Ketamine (2mg/kg = 0.2 ml/kg) are instilled in the nose, using a 1 ml syringe. The gesture will be directed by a physician having yet successfully completed a minimum of 50 intubations. After sedation completion, intubation decision will be taken at the onset of muscle relaxation or on the occurrence of apnea.\n\nThe clinical pain score will be evaluated on film a posteriori by two independent observers using a scale of hetero pain assessment.-Pain will be evaluated through the study of skin conductance.\nThe quality of intubation will be judged by the number of attempts required and by the duration of glottis exposure.\nHemodynamic and respiratory tolerances will be judged by measuring respectively variations in blood pressure, heart rate, FiO2 and the oxygen saturation.\n\nThe neurological follow-up will be carried out according to Brunet-Lezine developmental scale at the age of 2 years." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Respiratory Distress Syndrome", "Prematurity of Fetus" ] }, "KeywordList":{ "Keyword":[ "Intubation", "Delivery room", "Sedation", "Analgesia" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"62", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Ketamine Arm", "ArmGroupType":"Experimental", "ArmGroupDescription":"Phial of Ketamine (50mg/5ml) will be used and the dose administered will be 2 mg/kg.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Sedation by ketamine" ] } },{ "ArmGroupLabel":"Midazolam Arm", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Phials of midazolam (5mg/5ml)will be used and the dose administered will be 0.2 ml/kg.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Sedation with Midazolam" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Sedation by ketamine", "InterventionDescription":"Kétamine (50mg/5ml, Panpharma): for a posology of 2 mg/kg: dose of 0.2 ml/kg Intranasal administration with a 1 ml syringe. Kétamine is a derivated of phencyclidine with a sedative, anesthesic, analgesic and amnesiant activity. Ketamine keeps also a protective reflex of upper respiratory tracts.\n\nOne injection will be done and if after 7 minutes, newborn is not correctly sedated another dose of same product will be done.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ketamine Arm" ] } },{ "InterventionType":"Drug", "InterventionName":"Sedation with Midazolam", "InterventionDescription":"Midazolam (phyal of 5mg/5ml, Mylan S.A.S.) for a posology of 0.2 mg/kg: dose of 0.2 ml/kg Instillation in intranasal with a syringe of 1 ml. Midazolam is an imidazobenzodiazépine, witj a sedative and hypnotic activity,anxiolytic, anti convulsive and muscle relaxant proprieties.\n\nOne injection will be done and if after 7 minutes, newborn is not correctly sedated another dose of same product will be done.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Midazolam Arm" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Newborns sedation quality", "PrimaryOutcomeDescription":"The sedation quality of 2 newborns groups will be compared during the 10 minutes of intubation directly in delivery room and after on the film Pain evaluation done by a Specific clinical Score : the Faceless Acute Neonatal pain Scale (FANS) noted by two independent professional persons. And for Montpellier center, evaluation of pain by cutaneous conductance", "PrimaryOutcomeTimeFrame":"during the 10 minutes of intubation" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"intubation quality", "SecondaryOutcomeDescription":"Intubation quality will be evaluated and compared between the two groups by numbers of attempts, duration of glottis exposition (from introduction to withdrawal of laryngoscop)", "SecondaryOutcomeTimeFrame":"during the 10 minutes of intubation" },{ "SecondaryOutcomeMeasure":"hemodynamic and respiratory tolerance", "SecondaryOutcomeDescription":"Hemodynamic tolerance will be measured by Mean Arterial Pressure every 3 minutes before and after product instillation and during the intubation. After intubation, measure of Mean Arterial Pressure will be done every 10 minutes during 1 hour and after every hour until 24 hours. Cardiac frequency and cardiac fraquency variations will be measured and analyzed.\n\nRespiratory tolerance will be evaluated by continuing measure of SpO2, delay of instillation of surfactant dose and the need to administer un second dose of surfactant", "SecondaryOutcomeTimeFrame":"during 24 hours after intubation" },{ "SecondaryOutcomeMeasure":"neurological outcome at 2 years within the 2 groups", "SecondaryOutcomeDescription":"Prevalence of neurological complications (intraventricular hemorragies, periventricular leucomalacies), development quotient at 2 years (Brunet Lezine scale)will be evaluated and compared between the two groups", "SecondaryOutcomeTimeFrame":"2 years after the treatment" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nNeonates in delivery room\nPresence of respiratory distress syndrom requiring intubation (Silverman score> 3 and / or FiO2 greater than 30 % in premature infants under 30 weeks and over 40% after 30 weeks\nHemodynamic stability (mean arterial pressure> 3° percentile)\n\nExclusion Criteria:\n\nNeed for intubation in extreme emergency (pneumothorax, meconium aspiration, congenital diaphragmatic hernia, perinatal asphyxia)\nBirth in the absence of an independent appraiser\nMother under general anesthesia", "HealthyVolunteers":"No", "Gender":"All", "MaximumAge":"2 Hours", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Christophe CM MILESI, MD", "OverallOfficialAffiliation":"University Hospital, Montpellier", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Centre Hospitalier Universitaire", "LocationCity":"Montpellier", "LocationZip":"34000", "LocationCountry":"France" },{ "LocationFacility":"Centre Hospitalier Universitaire", "LocationCity":"Nimes", "LocationZip":"30000", "LocationCountry":"France" },{ "LocationFacility":"Centre Hospitalier Général", "LocationCity":"Perpignan", "LocationZip":"66000", "LocationCountry":"France" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"28818854", "ReferenceType":"derived", "ReferenceCitation":"Milési C, Baleine J, Mura T, Benito-Castro F, Ferragu F, Thiriez G, Thévenot P, Combes C, Carbajal R, Cambonie G. Nasal midazolam vs ketamine for neonatal intubation in the delivery room: a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2018 May;103(3):F221-F226. doi: 10.1136/archdischild-2017-312808. Epub 2017 Aug 17." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008874", "InterventionMeshTerm":"Midazolam" },{ "InterventionMeshId":"D000007649", "InterventionMeshTerm":"Ketamine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000778", "InterventionAncestorTerm":"Anesthetics, Dissociative" },{ "InterventionAncestorId":"D000018686", "InterventionAncestorTerm":"Anesthetics, Intravenous" },{ "InterventionAncestorId":"D000018681", "InterventionAncestorTerm":"Anesthetics, General" },{ "InterventionAncestorId":"D000000777", "InterventionAncestorTerm":"Anesthetics" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000018691", "InterventionAncestorTerm":"Excitatory Amino Acid Antagonists" },{ "InterventionAncestorId":"D000018683", "InterventionAncestorTerm":"Excitatory Amino Acid Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000759", "InterventionAncestorTerm":"Adjuvants, Anesthesia" },{ "InterventionAncestorId":"D000006993", "InterventionAncestorTerm":"Hypnotics and Sedatives" },{ "InterventionAncestorId":"D000014151", "InterventionAncestorTerm":"Anti-Anxiety Agents" },{ "InterventionAncestorId":"D000014149", "InterventionAncestorTerm":"Tranquilizing Agents" },{ "InterventionAncestorId":"D000011619", "InterventionAncestorTerm":"Psychotropic Drugs" },{ "InterventionAncestorId":"D000018757", "InterventionAncestorTerm":"GABA Modulators" },{ "InterventionAncestorId":"D000018682", "InterventionAncestorTerm":"GABA Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10428", "InterventionBrowseLeafName":"Midazolam", "InterventionBrowseLeafAsFound":"Midazolam", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M9257", "InterventionBrowseLeafName":"Ketamine", "InterventionBrowseLeafAsFound":"Ketamine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2688", "InterventionBrowseLeafName":"Anesthetics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2689", "InterventionBrowseLeafName":"Anesthetics, Dissociative", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19350", "InterventionBrowseLeafName":"Anesthetics, Intravenous", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19345", "InterventionBrowseLeafName":"Anesthetics, General", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19355", "InterventionBrowseLeafName":"Excitatory Amino Acid Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8626", "InterventionBrowseLeafName":"Hypnotics and Sedatives", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15488", "InterventionBrowseLeafName":"Anti-Anxiety Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M13057", "InterventionBrowseLeafName":"Psychotropic Drugs", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19411", "InterventionBrowseLeafName":"GABA Modulators", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AdjAn", "InterventionBrowseBranchName":"Adjuvants, Anesthesia" },{ "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"PsychDr", "InterventionBrowseBranchName":"Psychotropic Drugs" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000012127", "ConditionMeshTerm":"Respiratory Distress Syndrome, Newborn" },{ "ConditionMeshId":"D000012128", "ConditionMeshTerm":"Respiratory Distress Syndrome, Adult" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000012120", "ConditionAncestorTerm":"Respiration Disorders" },{ "ConditionAncestorId":"D000007235", "ConditionAncestorTerm":"Infant, Premature, Diseases" },{ "ConditionAncestorId":"D000007232", "ConditionAncestorTerm":"Infant, Newborn, Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M13547", "ConditionBrowseLeafName":"Respiratory Distress Syndrome, Newborn", "ConditionBrowseLeafAsFound":"Respiratory Distress Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13548", "ConditionBrowseLeafName":"Respiratory Distress Syndrome, Adult", "ConditionBrowseLeafAsFound":"Respiratory Distress Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M24456", "ConditionBrowseLeafName":"Premature Birth", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M26731", "ConditionBrowseLeafName":"Acute Lung Injury", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13540", "ConditionBrowseLeafName":"Respiration Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8862", "ConditionBrowseLeafName":"Infant, Premature, Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8859", "ConditionBrowseLeafName":"Infant, Newborn, Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4952", "ConditionBrowseLeafName":"Respiratory Distress Syndrome, Infant", "ConditionBrowseLeafAsFound":"Respiratory Distress Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T191", "ConditionBrowseLeafName":"Acute Respiratory Distress Syndrome", "ConditionBrowseLeafAsFound":"Respiratory Distress Syndrome", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BXS", "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }