[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-hypothyroidism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-hypothyroidism":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,75,96,115,142,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100625622","evaluation-of-an-intensified-systematic-screening-for-congenital-hypothyroidism-in-premature-newborns-100625622",false,"NCT07425028","Evaluation of an Intensified Systematic Screening for Congenital Hypothyroidism in Premature Newborns","PREMATHYRO","Inclusion Criteria:\n\n* Newborns born prematurely between 23 and 32 weeks of gestational age (up to 31 weeks and 6 days), both female and male, of all ethnic origins, regardless of birth weight, and including all other pathologies.\n* Newborns whose parents have given their non-opposition consent.\n\nExclusion Criteria:\n\n* Newborns born who leave the region before day 15.\n* Newborns who die before 15 days of age.\n* Newborns whose parents are not affiliated with the social security system.","ALL","23 Weeks","32 Weeks",{"count":20,"type":21},1600,"ESTIMATED","OBSERVATIONAL","Currently in France, screening for congenital hypothyroidism (CH) in premature infants is done by a single TSH assay on filter paper. However, European recommendations advise repeating the assay within the first month of life.\n\nOur primary objective is to estimate the incidence of CH in preterm infants under 32 weeks of gestational age by applying the European recommendations.",[25],"Congenital Hypothyroidism",[27,28,29],"congenital hypothyroidism","prematurity","screening","NOT_YET_RECRUITING","2026-05-20",{"date":33,"type":34},"2026-05-22","ACTUAL",{"date":36,"type":21},"2027-03",{"date":38,"type":21},"2028-03",{"name":40,"class":41},"University Hospital, Lille","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":52,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":42},"100640461","ultrasound-measurement-of-thyroid-volume-in-term-newborns-100640461","NCT07579988","Ultrasound Measurement of Thyroid Volume in Term Newborns","Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study","NEOTIR","Inclusion Criteria:\n\n* Healthy full term newborns (born between 37 and 42 weeks of gestation, with no antennal issue or complications at birth)\n* Consent obtained by parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n* Congenital malformations\n* TSH abnormalities in neonatal screening\n* Pregnancy not carried out in Italy, due to different iodine status\n* Inability or unwillingness of the parent(s) or legal guardian(s) to provide informed consent or to comply with study procedures",true,"1 Day","7 Days",{"count":55,"type":21},400,"First, to date, no data are available on the thyroid volume of full-term newborns in Italy, making it essential to conduct studies to establish reference values for normality. This allows these values to be correlated with maternal and fetal variability, providing a scientific basis for better understanding thyroid development in the first days of life. Thyroid ultrasound is useful for supplementing newborn screening for congenital hypothyroidism, helping to identify early abnormalities. Furthermore, thyroid volume is a sensitive indicator of iodine intake, essential for assessing the population's iodine nutritional status. It is equally valuable for studying and monitoring the effects of maternal and environmental factors, for which thyroid volume itself serves as a marker. Having normal values allows for a more precise comparison and contextualization of data from children with pathologies, who undergo ultrasound for pathological screening. In summary, these regulatory references improve the diagnosis, prevention, and management of neonatal thyroid dysfunction, contributing to a more informed public health.",[58,59,25,60],"Thyroid Volume","Thyroid Ultrasound","Healthy Newborns",[62,63,64,65],"thyroid","thyroid volume","reference values thyroid ultrasound","newborn","2026-05-05",{"date":68,"type":34},"2026-05-12",{"date":70,"type":21},"2026-05-01",{"date":72,"type":21},"2027-05-01",{"name":74,"class":41},"IRCCS Ospedale San Raffaele",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":42},"100571743","comparison-of-levothyroxine-formulations-in-the-treatment-of-congenital-hypothyroidism-100571743","NCT06724224","Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism","Inclusion Criteria:\n\nNewborn screening test positivity for Congenital Hypothyroidism; Subjects born in Emilia-Romagna region, Italy, and undergoing diagnostic confirmation and initiation of replacement therapy; Diagnosis-confirmed subjects who underwent L-T4 replacement therapy in the first month of life at Center for Endocrine-Metabolic Diseases, Pediatrics Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S.Orsola, Italy; Age ≤11 years old; Obtaining informed consent from parents and\u002For legal guardians and assent from minors included in the study.\n\nExclusion Criteria:\n\nKnown chromosomal abnormalities or complex syndromes; Patients transferred to another center before completion of at least one year of follow-up from the start of therapy; Patients who started therapy at another center.","11 Years",{"count":83,"type":21},120,"Observational, retrospective, prospective, pharmacological, single-centre, non-profit study.\n\nThe aim is to evaluate, in newborns diagnosed with Congenital Hypothyroidism, the medium- and long-term efficacy and safety of the new formulation of levothyroxine in oral solution, compared to the liquid drop formulation and the tablet formulation.\n\nThe study will involve male and female patients referred to the Neonatal Screening Centre at the Centre for Endocrine-Metabolic Diseases of the Paediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, Italy, who tested positive for Congenital Hypothyroidism.",[25],"RECRUITING","2026-03-11",{"date":89,"type":34},"2026-03-12",{"date":91,"type":34},"2024-04-08",{"date":93,"type":21},"2031-10-08",{"name":95,"class":41},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":42},"100572089","role-of-next-generation-sequencing-in-the-etiological-diagnosis-of-permanent-congenital-hypothyroidism-with-in-situ-thyroid-100572089","NCT06728735","Role of Next Generation Sequencing in the Etiological Diagnosis of Permanent Congenital Hypothyroidism With in Situ Thyroid","Role of Next Generation Sequencing in the Etiological Diagnosis of Permanent Congenital Hypothyroidism With in Situ Thyroid: Preliminary Data in Patients Followed at the Regional Neonatal Screening Centre for Endrocrine-Metabolic Disease in Bologna","Inclusion Criteria:\n\n* Patients born in Emilia-Romagna region, Italy, between January 2003 and December 2023;\n* Patients screened at the Regional Neonatal Screening Centre for Endrocrine-Metabolic Diseases, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy, and recalled for suspected congenital hypothyroidism;\n* Confirmed diagnosis of congenital hypothyroidism and in situ thyroid;\n* Hormonal and clinical follow-up of at least 36 months at Centre for Endrocrine-Metabolic Diseases, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Italy;\n* Obtaining informed consent from parents\u002Flegal guardians of paediatric patients.\n\nExclusion Criteria:\n\n• Patients with hypothyroidism associated with chromosomal syndromes.","18 Years",{"count":105,"type":21},350,"Retro-prospective, exploratory, single-centre observational study conducted at the Endrocrine-Metabolic Diseases Centre of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy.\n\nThe primary aim is to assess, by NGS sequencing of a panel of target genes, the frequency and type of variants with potential pathogenic significance in a patient population with congenital hypothyroidism and in situ thyroid, born between January 2003 and December 2023 identified through Neontal Screening at the Regional Centre for Neonatal Screening for Endrocrine-Metabolic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy.",[25],[25],{"date":89,"type":34},{"date":111,"type":34},"2021-03-17",{"date":113,"type":21},"2027-12-31",{"name":95,"class":41},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":51,"sex":16,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":42},"100614477","infants-with-primary-congenital-hypothyroidism-and-development-100614477","NCT07280104","Infants With Primary Congenital Hypothyroidism and Development","Investigation of Development Infants With Primary Congenital Hypothyroidism","Inclusion Criteria:\n\n* Those with primary congenital hypothyroidism who have been treated since the newborn period and are currently on treatment.\n* Infants born at term.\n* Between 6 and 18 months old.\n\nExclusion Criteria:\n\n* Infants with secondary congenital hypothyroidism,\n* Preterm infants,\n* Those with congenital infections or proven genetic alterations,\n* Infants diagnosed with metabolic, neurological, or genetic diseases,\n* Infants whose parents did not volunteer for the study","6 Months","18 Months",{"count":125,"type":21},40,"A review of the literature has focused primarily on the cognitive and motor development of children with congenital hypothyroidism, but no studies on sensory processing skills have been found. Considering the age range of the groups studied, studies conducted in the early stages of life are rare. This planned study aims to examine the neurological status, motor development, and sensory processing skills of infants aged 6-18 months, considering early synaptogenesis.",[25],[129,130,131,132],"Hypothyroidism","neurological status","motor development","sensory processing","2026-02-11",{"date":135,"type":34},"2026-02-12",{"date":137,"type":34},"2025-12-20",{"date":139,"type":21},"2026-12-20",{"name":141,"class":41},"Nigde Omer Halisdemir University",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":103,"enrollmentInfo":149,"targetDuration":4,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100582518","prospective-evaluation-of-optithydose-100582518","NCT06864351","Prospective Evaluation of OptiThyDose","Prospective Evaluation of OptiThyDose, a Mathematical Model for Calculating Appropriate Dose Ranges in Children With Thyroid Diseases","Inclusion Criteria:\n\nCongenital hypothyroidism (CH)\n\n* Newborns with pathological neonatal screening and confirmation of an increased Thyrotropin (TSH) level in an independent venous blood sample\n\nGraves' disease (GD)\n\n* Children until 18 years with new diagnosis of GD, recurrence of GD, or insufficiently controlled GD under CMZ\u002FMMZ during follow-up according to:\n\n  * Pathological lab values (suppressed TSH, increased thyroid hormone levels, positive Anti-TSH-receptor antibodies)\n  * Typical clinical picture, if present (goitre, tachycardia, palpitations, weight loss, hyperphagia, altered mood)\n\nCH and GD\n\n* The study participant must be accessible for scheduled visits, treatment and follow-up.\n* Signed Informed Consent form (ICF) obtained prior to any study related procedure. Written IC for study participation must be signed and dated by the patient and\u002For his\u002Fher legal representative(s) in accordance with national legal requirements\n\nExclusion Criteria:\n\nCH and GD\n\n* Exclusion of newborns from mothers with GD\n* Exclusion of patients in case of a life-threatening event\n\nGD\n\n* Exclusion of children with known other aetiologies of hyperthyroidism than GD without elevated Anti-TSH-receptor antibodies e.g.:\n\n  * known toxic thyroid nodules proven by ultrasound\u002Fscintigraphy\n  * known amiodarone induced hyperthyroidism\n  * known McCune Albright syndrome (based on clinical, laboratory, and genetic diagnosis) associated hyperthyroidism\n  * known genetically proven hyperthyroidism caused by activating mutations of the TSH receptor gene",{"count":150,"type":21},150,"INTERVENTIONAL",[153],"NA","The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).",[156,25,157],"Thyroid Diseases","Graves Disease","2025-09-01",{"date":160,"type":34},"2025-09-03",{"date":162,"type":34},"2025-08-28",{"date":164,"type":21},"2029-02",{"name":166,"class":41},"University Children's Hospital Basel",2,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":51,"sex":16,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":180,"studyType":22,"phases":4,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":42},"100602656","metabolic-risk-assessment-in-prepubertal-children-with-congenital-hypothyroidism-100602656","NCT07126353","Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism","Metabolic Risk Assessment in Prepubertal Children With Congenital Hypothyroidism (IpoMet)","IpoMet","Inclusion Criteria:\n\n* Pubertal stage Tanner 1\n* Permanent congenital hypothyroidism\n* All ethnic groups\n* Informed consent signature\n\nExclusion Criteria:\n\n* Age\\\u003C 5 years\n* Pubertal stage Tanner 2-5\n* Transient congenital hypothyroidism or other type of hypothyroidism","5 Years","12 Years",{"count":179,"type":21},170,"12 Months","We propose a multicenter prospective study to define the prevalence and severity score of metabolic syndrome in a prepubertal pediatric cohort with congenital hypothyroidism, compared to a healthy and normal-weight pediatric population. These data will help to define whether hypothyroidism can be considered a risk factor for the metabolic health of the pediatric population. The possible identification of an at-risk metabolic profile will provide useful information to optimize the diagnostic and monitoring pathway for affected children.",[25,183],"Metabolic Syndrome",[185,186,187],"Congenital hypothyroidism","metabolic syndrome","Obesity","2025-08-10",{"date":190,"type":34},"2025-08-17",{"date":192,"type":21},"2025-09",{"date":194,"type":21},"2026-10",{"name":196,"class":41},"Buzzi Children's Hospital"]