[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513742":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":10,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Cologne","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"fathers of mature infants",null,"Fathers of newborns' above 37 weeks of gestation",[13],"Diagnostic Test: measurement of cortisol level",{"label":15,"type":10,"description":16,"interventionNames":17},"fathers of moderate and late preterm infants","Fathers of moderate and late preterm infants, i.e. gestational age from 32 0\u002F7 to 36 6\u002F7 weeks of gestation.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"fathers of very low birth weight preterm infants","Fathers of very low birth weight preterm infants, i.e. gestational age from 22 0\u002F7 to 31 6\u002F7 weeks of gestation and with a birth weight below 1500 g.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","measurement of cortisol level","We will measure the cortisol level from the hair sample of the father at three time points. Furthermore the father will answer questionnaires at three time points and the paternal sensitivity is measured once.",[9,15,19],[29],"questionnaire",[31],{"name":32,"affiliation":5,"role":33},"Katrin Mehler, PD Dr.","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Eva Heine, Dr. med.","CONTACT","004922147885663","eva.heine@uk-koeln.de",{"name":32,"role":37,"phone":38,"phoneExt":10,"email":41},"katrin.mehler@uk-koeln.de",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University Hospital of Cologne","RECRUITING","Cologne","Northrhine-westfalia","50931","Germany","DE",{"type":52,"coordinates":53},"Point",[54,55],6.95,50.93333,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":38,"phoneExt":10,"email":41},"Katrin Mehler, PhD",{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Katrin Mehler","Associate Professor",[64],{"name":65,"class":66},"University of Siegen","UNKNOWN","100513742","hair-cortisol-as-marker-of-chronic-stress-in-preterm-and-term-fathers---fathair-study-100513742",false,"NCT05969431","Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study","Inclusion Criteria:\n\n* Premature or mature infant (22 0\u002F7 to 42 0\u002F7 weeks of gestation)\n* For mature infants (37 0\u002F7 to 42 0\u002F7 weeks of gestation) undisturbed neonatal period\n* No severe malformations or genetic diseases of the newborn child\n* Sufficient knowledge of German of the father\n* written consent of the custodial parents\n\nExclusion Criteria:\n\n* adoptive or foster paternity\n* hair length below 3 cm at the posterior vertex region of the back of the father's head\n* endocrine disorders, especially of the adrenocortical system (e.g. Cushing syndrome, adrenal insufficiency)\n* taking steroidal medications or other drugs that affect the activity of the hypothalamic-pituitary-adrenocortical system\n* paternal psychological or severe physical illness",true,"ALL","1 Day","7 Days",{"count":78,"type":79},120,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to compare the paternal hair cortisol as a marker for chronic stress in prematurely born children to maturely born children.\n\nThe main questions it aims to answer are:\n\n* How differ the cortisol level between groups?\n* How change the cortisol level over time?\n* Are there secondary outcomes associated to the cortisol level of fathers? Participants will give a hair sample to analyse the cortisol level and fill out questionnaires at three time points. At six months of the infant's age, the investigators will also measure the paternal sensitivity.",[83,84,85],"Stress, Psychological","Father-Child Relations","Premature Birth","2024-11-24",{"date":88,"type":89},"2024-11-27","ACTUAL",{"date":91,"type":89},"2024-10-01",{"date":93,"type":79},"2025-12-31",{"name":5,"class":6},1]