Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:38 PM
Study NCT ID:
NCT04712760
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003409', 'term': 'Congenital Hypothyroidism'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.', 'timeFrame': '42 months'}], 'secondaryOutcomes': [{'measure': 'Compare the dose of Levothyroxine between children with transient and permanent congenital hypothyroidism at 6 months, 1 year, 2 years and 3 years follow-up.', 'timeFrame': '6 months, 1 year, 2 years, 3 years'}, {'measure': 'Assess the percentage of children with psychomotor impairment at the age of 3,5 years in both groups.', 'timeFrame': '42 months'}, {'measure': 'Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening).', 'timeFrame': '42 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eutopic thyroid gland', 'transient hypothyroidism'], 'conditions': ['Congenital Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '36798001', 'type': 'DERIVED', 'citation': 'Bontemps SH, Legagneur C, Gueant-Rodriguez RM, Remen T, Luc A, Renard E. Congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis: prognostic factors for transient vs. permanent hypothyroidism. J Pediatr Endocrinol Metab. 2023 Feb 20;36(4):353-363. doi: 10.1515/jpem-2022-0101. Print 2023 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Clinical practice guidelines recommend to re-evaluate thyroid function in children with eutopic gland around the age of 3 years to determine whether hypothyroidism is transient or permanent. Up until today it is still difficult to determine early on whether hypothyroidism is transient or permanent in children with eutopic gland. Our aim is to identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with congenital hypothyroidism either detected by newborn screening or by a blood test done because of clinical suspicion of hypothyroidism, in Lorraine, between 1996 and 2017. All the patients with confirmed hypothyroidism underwent thyroid imaging. The children with eutopic gland and hemiagenesis are included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with congenital hypothyroidism\n* Eutopic thyroid gland or thyroid hemiagenesis\n* Born between 1996 and 2017\n* Treated at the Nancy Regional and University Hospital\n* Follow-up of at least 3,5 years.\n\nExclusion Criteria:\n\n* Polymalformative syndrome\n* Thyroid dysgenesis except for thyroid hemiagenesis'}, 'identificationModule': {'nctId': 'NCT04712760', 'briefTitle': 'Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.', 'orgStudyIdInfo': {'id': '2020PI260'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transient congenital hypothyroidism', 'description': '\\- children with congenital hypothyroidism who are no longer treated with Levothyroxine at an age of 3 years and 6 months'}, {'label': 'Permanent congenital hypothyroidism', 'description': '\\- children with congenital hypothyroidism who are still treated with Levothyroxine at an age of 3 years and 6 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emeline Renard, MD', 'role': 'CONTACT', 'email': 'e.renard@chru-nancy.fr', 'phone': '+33 3 83 15 45 00'}, {'name': 'Sylvie Hélène Bontemps', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Emeline Renard, MD', 'role': 'CONTACT', 'email': 'e.renard@chru-nancy.fr', 'phone': '+33 3 83 15 45 00'}], 'overallOfficials': [{'name': 'Emeline Renard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'RENARD Emeline', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}