[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569011":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":114,"collaborators":12,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":12,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Umeå University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Controll group","NO_INTERVENTION","Standard care",null,{"label":14,"type":6,"description":15,"interventionNames":16},"INSPIRE-intervention","Intervention group, recieving the INSPIRE-intervention",[17],"Behavioral: Neurodevelopmental support",[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","Neurodevelopmental support","The Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health (INSPIRE) aims to support the infant's neurodevelopment by supporting the parents to develop a responsive approach. The intervention will enhance the infant's social and environmental interactions, focusing on developing both the infant's and parent's strengths, seeking opportunities instead of problems in behaviour, enhancing mutually satisfying interaction and parental empowerment.",[14],[25],{"name":26,"affiliation":27,"role":28},"Magnus Domellöf, Professor","Umeå universitet","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Malin Bergman Papworth, PhD-student","CONTACT","0046 730438397","malin.bergman.papworth@umu.se",[36,50,60,70,80,94,104],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":12},"Falu County Hospital","RECRUITING","Falun","Dalarna County","791 82","Sweden","SE",{"type":45,"coordinates":46},"Point",[47,48],15.62597,60.60357,{"lat":48,"lon":47},{"facility":51,"status":38,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":12},"Östersund Hospital","Östersund","Jämtland Härjedalen","831 83",{"type":45,"coordinates":56},[57,58],14.63566,63.1792,{"lat":58,"lon":57},{"facility":61,"status":38,"city":62,"state":63,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":12},"Sunderby Hospital","Södra Sunderbyn","Norrbotten County","954 42",{"type":45,"coordinates":66},[67,68],21.94004,65.65983,{"lat":68,"lon":67},{"facility":71,"status":38,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":12},"Karlstad Hospital","Karlstad","Värmland County","651 85",{"type":45,"coordinates":76},[77,78],13.50357,59.3793,{"lat":78,"lon":77},{"facility":81,"status":38,"city":82,"state":83,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Umeå university hospital","Umeå","Västerbotten County","90185",{"type":45,"coordinates":86},[87,88],20.25972,63.82842,{"lat":88,"lon":87},[91],{"name":92,"role":32,"phone":93,"phoneExt":12,"email":12},"Malin C Bergman Papworth, PhD student","+46730438397",{"facility":95,"status":38,"city":96,"state":97,"zip":98,"country":42,"countryCode":43,"cosmosGeoPoint":99,"geoPoint":103,"contacts":12},"Sundsvall Hospital","Sundsvall","Västernorrland County","856 43",{"type":45,"coordinates":100},[101,102],17.3063,62.39129,{"lat":102,"lon":101},{"facility":105,"status":38,"city":106,"state":107,"zip":108,"country":42,"countryCode":43,"cosmosGeoPoint":109,"geoPoint":113,"contacts":12},"Örebro University Hospital","Örebro","Örebro County","701 15",{"type":45,"coordinates":110},[111,112],15.2066,59.27412,{"lat":112,"lon":111},{"type":115,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100569011","intervention-for-neurodevelopmental-support-in-preterm-infants-using-responsive-parenting-and-e-health-100569011",false,"NCT06688695","Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health","Intervention for Neurodevelopmental Support in Preterm Infants Using Responsive Parenting and E-health (INSPIRE)","INSPIRE","Inclusion Criteria:\n\n\\* Infant born before 32 GV, or with birth weight under 1500 gr.\n\nExclusion Criteria:\n\n* Parent(s) younger than 18 ya.\n* Chromosomal abnormalities, congenital syndromes that may affect the child's development.\n* Parents unable to understand Swedish.\n* Parents with severe mental illness or a physical medical condition requiring extensive inpatient care.\n* Families without a stable living situation, such as parental substance abuse, homelessness, or family living under threat of deportation from Sweden.\n* Families that have previously participated in the INSPIRE study or the INSPIRE pilot study.","ALL","0 Months","4 Months",{"count":128,"type":129},176,"ESTIMATED","INTERVENTIONAL",[132],"NA","Research problem and specific questions More than 1000 very preterm infants (\\< 32 weeks) are born every year in Sweden. They are at high risk of neurodevelopmental disabilities and mental illness throughout the lifespan.\n\nThe overall purpose is to develop and evaluate a novel e-health intervention aimed at improving neurodevelopment (cognitive, motor, feeding, language, socio-emotional) of very preterm infants by supporting responsive parenting behaviours.\n\nThe primary research question is whether the intervention improves child neurodevelopment up to 2 years.\n\nFurther research questions relate to the emotional availability of parents and children, parental stress and overall experience as well as effects on health inequalities and gender effects.\n\nData and method Using a multi-professional approach, the study team have developed a post-discharge \"Intervention for Neurodevelopmental Support in Preterm Infants using Responsive parenting and E-health\" (INSPIRE). Parents of very preterm infants will be included in the program at hospital discharge and will receive the intervention in 18 sessions over a two year period.\n\nThe study team have assessed feasibility and refined the intervention in a pilot study including 9 families. This autumn, a randomized clinical trial will be performed to evaluate efficiency: Families will be randomized to the INSPIRE program or standard care. Follow-up and assessment of children (and parents) across a range of crucial domains will be performed up to at least 2 years of age.\n\nSocietal relevance and utilisation The project will be the first in the world to use a digital e-health solution with video interaction to deliver a post discharge parental support intervention to parents of very preterm infants. The project has great potential to reduce the risk of cognitive impairment, behavioral problems, mental illness and eating disorders in these high risk children, as well as improving mental health and well-being in the parents. Parents of preterm infants are involved as co-creators in developing and evaluating the program.\n\nPlan for project realization Currently, there is no similar post-discharge program available. Based on the results, the study team aim to implement a sustainable, nationwide, post-discharge e-health intervention program to improve health in very preterm-born children and their parents, which will also reduce health inequality by ensuring the availability of high-quality support to families living far away from highly specialized health care facilities",[135,136],"Premature Infant","Premature Babies",[138,139,140,141],"Early intervention","Responsive parenting","E-health","Prematurity","2026-01-27",{"date":144,"type":145},"2026-01-28","ACTUAL",{"date":147,"type":145},"2024-11-20",{"date":149,"type":129},"2029-10",{"name":5,"class":6},7]