[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preschool-age-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preschool-age-children":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100617324","the-effectiveness-of-early-immunisation-with-nirsevimab-on-preschool-wheezing-in-france-based-on-an-analysis-of-data-from-the-french-health-system-database-100617324",false,"NCT07317141","The Effectiveness of Early Immunisation With Nirsevimab on Preschool Wheezing in France, Based on an Analysis of Data From the French Health System Database.","Effectiveness of Early Immunization With Nirsevimab on Preschool Wheezing in France","INSPIRATION","Inclusion Criteria:\n\n* \\- Exposed group of children: all children born between 06\u002F02\u002F2023 and 31\u002F01\u002F2024 and who had received nirsevimab before 6 or 12 months of age depending on the outcomes that will be studied.\n* Unexposed group of children: all children born between 06\u002F02\u002F2023 and 31\u002F01\u002F2024 and who did not receive nirsevimab\n\nExclusion Criteria:\n\n* \\- Infants born in Overseas Departments and Territories (Guadeloupe, Martinique, Guyana, La Réunion, Mayotte, Saint-Pierre-et-Miquelon, French Polynesia, Nouvelle-Calédonie, Wallis-et-Futuna, French Southern and Antarctic Lands, Clipperton island)\n* Same-sex twins, as they cannot be differentiated in the French Medicalization of Information Systems Program (PMSI)\n* Infants born between 06\u002F02\u002F2023 and 31\u002F01\u002F2024 in a maternity unit that has not reported data on the immunization with nirsevimab\n* Infants whose mother had been vaccinated against RSV during pregnancy\n* Infants who received palivizumab immunization\n* Date of nirsevimab immunization not provided\n* Infants hospitalized for wheezing or RSV+ lower respiratory tract infection before receiving nirsevimab\n* Infants who were immunized after 12 months of age for outcomes collected between 2 and 6 years old\n* Infants who were immunized after 6 months of age for outcomes collected during the second year of life","ALL","1 Year",{"count":20,"type":21},218000,"ESTIMATED","OBSERVATIONAL","Early respiratory syncytial virus (RSV) bronchiolitis is a well-known contributing factor of mid- and long-term respiratory sequelae in children such as recurrent lower tract respiratory infections (LRTIs), preschool wheezing (PW) or decreased lung function at older ages.\n\nNirsevimab, a monoclonal antibody against RSV with enhanced neutralizing activity and a prolonged half-life, has shown great potential in reducing short term outcomes such as hospitalization for RSV associated bronchiolitis (estimated adjusted effectiveness against hospitalization to 83.0% (95%CI: 73.4 to 89.2). Other countries that have been using nirsevimab almost exhaustively have reported similar results such as in Galicia.\n\nHowever, prevention of RSV LRTI or delay RSV infection early in life has not been investigated on respiratory manifestations such early wheezing in infancy (ie before 2 years of age) and recurrent wheezing in preschool period (ie between 2 and 6 years old).\n\nSome recent data have shown that nirsevimab was associated with a reduction of wheezing in the year following its administration (HR: 0.73; 95% CI, 0.58-0.93). Other data have shown that not being infected by RSV during the infancy was associated with 26% lower risk of 5-year current asthma than being infected (5) giving good rational for preventive strategies against RSV to impact midterm respiratory outcomes such as PW and then asthma.\n\nOngoing observational cohort studies will help investigate the question of mid-term effects, but they will come with a high costs and risk of attrition. Administrative national health claims database could prove to be useful and complementary by studying these types of real world outcomes across lives of children that have been immunized by nirsevimab as shown recently.\n\nTherefore, the investigators aim to study the impact of early nirsevimab administration on wheezing manifestations occurring in infancy and beyond during the preschool years.\n\nOur primary objective is to see if nirsevimab administration during the first six months of life has an impact on hospitalization for wheezing episodes during the second year of life, based on the hypothesis that infants who had received nirsevimab have reduced hospitalization for wheezing during their second year of infancy.",[25,26,27],"Infant Wheeze","Preschool Age Children","Asthma Childhood",[29,30,31,32],"nirsevimab","wheezing disease","infants","preschoolers","NOT_YET_RECRUITING","2026-01-06",{"date":36,"type":37},"2026-01-08","ACTUAL",{"date":39,"type":21},"2026-01-01",{"date":41,"type":21},"2029-06-01",{"name":43,"class":44},"Hospices Civils de Lyon","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100597135","engaging-mental-health-services-for-preschoolers-at-risk-100597135","NCT07054554","Engaging Mental Health Services for Preschoolers at Risk","NTRI-MH","Inclusion Criteria:\n\n* Family Navigators: Having experience working as family navigator and\u002For community health worker; Latinx, Black or White; \\> 18 years old.\n* Caregivers: current caregiver of a HStart preschooler at-risk for MH disorders (ASQ-SE above threshold score)\n* Teachers: Current Head Start (HStart) teacher from one of the 2 HStart site;\\> 18 years old; Any race\u002Fethnicity.\n* PCPs: Currently providing primary care for HStart preschool age children at risk for MH disorders; \\> 18 years old; Any race\u002Fethnicity.\n\nExclusion Criteria:\n\n* Unable to read\u002Fspeak either English or Spanish.","18 Years",{"count":55,"type":21},106,"INTERVENTIONAL",[58],"NA","Most mental health (MH) disorders develop in early childhood but are not clinically identified or treated until later-delaying treatment services that could prevent the enduring effects of long-term MH problems. Moreover, low income, ethno-racial minoritized children who exhibit higher rates of persistent MH disorders, are at greater risk for lags in identification and treatment. Head Start (HStart) has shown early school success for low-income children, aged 3-5 years, who are disproportionately Black or Latinx. HStart monitors early childhood MH symptoms, yet studies have found that when detected, only those most impaired are referred for treatment. In our research, the investigators learned that system and individual level barriers preclude early treatment among HStart preschoolers with developmental concern. The investigators showed that caregivers encountered system barriers of HStart teachers and primary care providers (PCPs) falling behind in referrals for intervention, and caregiver beliefs about stigma, their limited knowledge and distrust of healthcare hindered early engagement in services. Studies on MH treatment obstacles for low-income, ethno-racial minoritized people illustrate similar barriers to those found among HStart preschoolers with developmental concern. We developed and tested an ethno-racially matched, peer-based family navigator program for HStart preschoolers with developmental concern. Navigators used trust and empowerment to increase caregiver advocacy thereby leading to improved professional alliances and treatment. A navigator program for those with primary MH concerns has not been trialed. For Aim 1, the investigators aim to tailor and trial in a case series the Navigate-Train-Referral-Intervention Mental Health (NTRI-MH) intervention to promote access, engagement, coordination, and optimization of services for preschoolers with MH symptoms. The investigators have used focus group feedback from caregiver, navigator, HStart teacher, and PCP stakeholders to adapt NTRI-MH and created a web-based dashboard to monitor outcomes (Phase 1). Then, for phase 2, the investigators will conduct a feasibility study for caregivers of HStart preschoolers with MH symptoms, guided by ethno-racially matched family navigators and referrals by HStart teachers and PCPs (n=20). Further, for Aim 2, the investigators will pilot test NTRI-MH for caregivers of preschoolers with MH symptoms compared to an active control group of caregivers who receive child behavior training (n=86). The investigators will trial the effectiveness of the NTRI-MH mechanisms of caregiver beliefs on MH, empowerment, and professional alliances on family functioning and child emotion regulation. If the aims of the project are achieved, this study would have a large impact on early MH service use for ethno-racial minoritized young children with the potential to improve child MH outcomes.",[61,62,63,26],"Mental Health Disorder","Family Navigation","Minoritized Population",[62,65,26],"mental health disorder","RECRUITING","2025-08-19",{"date":69,"type":37},"2025-08-24",{"date":71,"type":37},"2025-07-01",{"date":73,"type":21},"2027-07-31",{"name":75,"class":44},"Children's Hospital Medical Center, Cincinnati"]