Nctid:
NCT06616012
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D047928", "term"=>"Premature Birth"}], "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"}], "browseLeaves"=>[{"id"=>"M25869", "name"=>"Premature Birth", "asFound"=>"Preterm Birth", "relevance"=>"HIGH"}, {"id"=>"M10772", "name"=>"Obstetric Labor, Premature", "relevance"=>"LOW"}, {"id"=>"M10764", "name"=>"Obstetric Labor Complications", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2023-09-14", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-03-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Clinical complications with the Neosense catheter.", "timeFrame"=>"During study, up to 5 days", "description"=>"The number of occasions when the Neosense catheter had to be removed and the underlying reason. This includes all anticipated device effects as well as placing the catheter in the wrong vessel, impossible to measure blood pressure, collect blood samples and/or administer fluids."}], "secondaryOutcomes"=>[{"measure"=>"Measurement performance (continuously) of an intravascular oxygen sensor in the Neosense system", "timeFrame"=>"Measurement comparisons done at every blood gas sample, i.e. every 4th - 6th hour during the study (up to 5 days)", "description"=>"The oxygen tension measured by the Neosense system, compared to the oxygen tension measured by a blood gas analyser."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isUnapprovedDevice"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["neonatal", "arterial oxygen tension", "oxygen therapy"], "conditions"=>["Catheters, Indwelling", "Preterm Birth", "Compromised Health"]}, "descriptionModule"=>{"briefSummary"=>"The study is a non-blinded trial with one single intervention in sick newborn infants. The Neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. The catheter will be connected to the Neosense monitor/measuring unit.\n\nBlood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). Oxygen tension data from the Neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. This data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. The blood gas samples will be analysed according to clinical and laboratory routine.\n\nThe infants will remain in the study as long as the Neosense measuring system is used"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"1 day", "minimumAge"=>"0 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nSick newborn infants where the clinical routine indicates use of an umbilical catheter. At least one of the criteria below should be fulfilled:\n\n* The infant needs invasive measurement of blood pressure.\n* The infant needs repetitive sampling of blood.\n* The infant needs prolonged infusion(s) \\> 2 days.\n* The infant needs infusion of vessel irritating and potentially vessel harming solutions.\n* The infant is born extremely preterm (before 28+0 weeks gestational age).\n* A newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% Fraction of inspired oxygen (FiO2)).\n* The infant is undergoing therapeutic hypothermia following asphyxia \\"oxygen deficiency at birth\\").\n* The infant has a severe infection/sepsis.\n\nAlso:\n\n• Signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required).\n\nExclusion Criteria:\n\n* Gastroschisis\n* Omphalocele\n* Peritonitis\n* Necrotizing enterocolitis\n* Omphalitis\n* The infant has a severe infection/sepsis\n* Expected MRI investigation within the 7 first days after birth\n* The infants birth weight is below 750 g\n* The infant is born before week 25+0\n* Local vascular compromise in lower limbs or buttocks area, or portal venous hypertension"}, "identificationModule"=>{"nctId"=>"NCT06616012", "acronym"=>"IMPROVE", "briefTitle"=>"Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Neosense Technologies"}, "officialTitle"=>"Evaluation of Intravascular Monitoring of Partial PRessure of Oxygen for Neonatal IntensiVE Care Patients -3", "orgStudyIdInfo"=>{"id"=>"IMPROVE-3"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Neosense Umbilical Catheter", "description"=>"The Neosense umbilical catheter is used instead of the routinely used umbilical catheter", "interventionNames"=>["Device: Neosense umbilical catheter"]}], "interventions"=>[{"name"=>"Neosense umbilical catheter", "type"=>"DEVICE", "description"=>"The Neosense umbilical catheter is used instead of a standard umbilical catheter", "armGroupLabels"=>["Neosense Umbilical Catheter"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Gothenburg", "state"=>"Halland", "country"=>"Sweden", "facility"=>"Östra/Sahlgrenska University Hospital", "geoPoint"=>{"lat"=>57.70716, "lon"=>11.96679}}, {"city"=>"Lund/Malmö", "state"=>"Skåne", "country"=>"Sweden", "facility"=>"Skåne University Hospital"}, {"city"=>"Uppsala", "state"=>"Uppland", "country"=>"Sweden", "facility"=>"Uppsala University Children's Hospital", "geoPoint"=>{"lat"=>59.85882, "lon"=>17.63889}}, {"city"=>"Västerås", "state"=>"Västmanland", "country"=>"Sweden", "facility"=>"Västmanalands Hospital", "geoPoint"=>{"lat"=>59.61617, "lon"=>16.55276}}, {"city"=>"Stockholm", "country"=>"Sweden", "facility"=>"Karolinska University Hospital", "geoPoint"=>{"lat"=>59.33258, "lon"=>18.0649}}, {"city"=>"Stockholm", "country"=>"Sweden", "facility"=>"Södersjukhuset", "geoPoint"=>{"lat"=>59.33258, "lon"=>18.0649}}], "overallOfficials"=>[{"name"=>"Richard Sindelar, MD, PhD, Associate professor", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Uppsala University Children's Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Neosense Technologies", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
