[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100367430":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":36,"overallOfficials":42,"centralContacts":47,"locations":56,"responsibleParty":72,"collaborators":20,"id":74,"slug":20,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":20,"studyType":86,"phases":20,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":58,"whyStopped":20,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Imperial College Healthcare NHS Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Haemodynamic outcome comparison to echocardiography measured CO","Non-invasive continuous Cardiac Output (CO) measurement (mls\u002Fkg\u002Fmin) during the first month of life in comparison to echocardiography measured CO (mls\u002Fkg\u002Fmin)","36 months",{"measure":14,"description":15,"timeFrame":12},"Changes in cardiac output","Changes in cardiac output (CO) measurement (mls\u002Fkg\u002Fmin) in relation to neonatal intervention",[17],{"measure":18,"description":19,"timeFrame":12},"Changes in clinical outcome - Survival at discharge","Survival at discharge",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"COHORT","PROSPECTIVE","This is a 3-year prospective observational study.\n\nPrincipal research question:\n\nIs non-invasive continuous cardiac output (CO) measurement a validated tool of comprehensive cardiovascular assessment in neonatal intensive care (NICU)?\n\nSecondary research questions:\n\n1. Can robust normal ranges of CO be constructed for neonates undergoing cardiovascular measurement?\n2. How do neonatal interventions (fluid boluses, ventilation and inotropes) affect CO?\n3. Does the Non-invasive continuous cardiac output monitoring in children with foetal growth restriction (FGR) differ from normative CO data as above (1)?\n\nA prospective study of stable newborn babies in the postnatal ward and sick term and preterm infants in the NICU in 36 months.","All term and preterm infants (24-42 weeks of gestational age) for the validation study and preterm infants with fetal growth restriction for the longitudinal study.",[27,32],{"label":28,"type":20,"description":29,"interventionNames":30},"Babies (24-42 weeks)","All babies born between 24 and 42 weeks",[31],"Device: NICAS cardiac output monitor",{"label":33,"type":20,"description":34,"interventionNames":35},"Preterm infants","Preterm infants with fetal growth restriction",[31],[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":20},"DEVICE","NICAS cardiac output monitor","Non-invasive continuous cardiac output monitoring device using total body bioimpedance.",[28,33],[43],{"name":44,"affiliation":45,"role":46},"Jayanta Banerjee","Neonatal consultant","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":20,"email":52},"Jayanta Banerjee Imperial College Healthcare NHS Trust","CONTACT","02033137308","jayanta.banerjee@nhs.net",{"name":54,"role":50,"phone":51,"phoneExt":20,"email":55},"Sundar Sathiyamurthy Imperial College Healthcare NHS Trust","s.sathiyamurthy@nhs.net",[57],{"facility":5,"status":58,"city":59,"state":20,"zip":20,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","London","United Kingdom","UK",{"type":63,"coordinates":64},"Point",[65,66],-0.12574,51.50853,{"lat":66,"lon":65},[69],{"name":70,"role":50,"phone":20,"phoneExt":20,"email":71},"Becky Ward","Becky.Ward@imperial.ac.uk",{"type":73,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100367430",false,"NCT04064177","Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study","NICCOM","Inclusion Criteria:\n\n* Healthy term infants in postnatal ward (within the first 72 hours of age)\n* Term and Preterm infants (including those with FGR) admitted to the neonatal unit\n* Written informed parental consent (prospective for postnatal ward and retrospective for babies admitted to the neonatal units)\n\nExclusion Criteria:\n\n* Antenatal or postnatal diagnosis of severe congenital anomaly\n* Infants with no realistic chance of survival\n* Infants who are \\>12 hours of age\n* Infants with fragile skin not permitting skin probe placement","ALL","1 Hour","40 Weeks",{"count":84,"type":85},148,"ESTIMATED","OBSERVATIONAL","This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.",[89,90,91],"Cardiac Output, Low","Cardiac Output, High","Blood Pressure",[91],"2024-07-26",{"date":95,"type":96},"2024-07-29","ACTUAL",{"date":98,"type":96},"2019-10-24",{"date":100,"type":85},"2024-12-31",{"name":5,"class":6},1]