Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-28 @ 11:32 PM
Study NCT ID:
NCT02374593
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2015-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eeugster@iu.edu', 'phone': '317 944-3889', 'title': 'Dr. Erica Eugster', 'organization': 'Riley Hospital for Children'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Adverse events were not monitored as all subjects were treated according to existing clinical standards of care', 'eventGroups': [{'id': 'EG000', 'title': 'Targeted Dosing', 'description': 'Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Historical Control', 'description': 'Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose Adjustments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Targeted Dosing', 'description': 'Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.'}, {'id': 'OG001', 'title': 'Historical Control', 'description': 'Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '0.334', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.211', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded.', 'unitOfMeasure': 'Number of dose adjustments', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Athyreosis', 'description': 'Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy at 15 mcg/kg for athyreosis.\n\nLevothyroxine: Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.\n\nUltrasound'}, {'id': 'OG001', 'title': 'Patients With Dysgenetic Thyroids', 'description': 'patients with dysgenetic thyroids'}, {'id': 'OG002', 'title': 'Patients With Eutopic Thyroids', 'description': 'patients with eutopic thyroids'}, {'id': 'OG003', 'title': 'Historical Controls', 'description': 'see title'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '0.275', 'groupId': 'OG000'}, {'value': '2', 'spread': '0.275', 'groupId': 'OG001'}, {'value': '1', 'spread': '0.275', 'groupId': 'OG002'}, {'value': '2', 'spread': '0.275', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results', 'unitOfMeasure': 'dose adjustments', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Targeted Dosing', 'description': 'Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.'}, {'id': 'FG001', 'title': 'Historical Control', 'description': 'Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Targeted Dosing', 'description': 'Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.'}, {'id': 'BG001', 'title': 'Historical Control', 'description': 'Patients in this arm were treated with levothyroxine empirically with an initial dose between 10-15 mcg/kg/day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-06', 'studyFirstSubmitDate': '2015-02-18', 'resultsFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-06', 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Adjustments', 'timeFrame': '6 months', 'description': 'Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded.'}], 'secondaryOutcomes': [{'measure': 'Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls', 'timeFrame': '6 months', 'description': 'Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Congenital Hypothyroidism']}, 'descriptionModule': {'briefSummary': 'This is a clinical study comparing targeted levothyroxine dosing based on thyroid anatomy as visualized on ultrasound (normal vs. ectopic/sublingual vs. athyreosis) to empiric levothyroxine dosing in infants with congenital hypothyroidism. Patients enrolled in the study for targeted dosing will be compared to controls obtained by retrospective chart review. The main outcome is to determine if there is a difference in the frequency of over-treatment and under-treatment during the first 6 months of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborns diagnosed with congenital hypothyroidism (CH).\n* Newborns with CH who are treated by a pediatric endocrinologist at Riley Hospital for Children or satellite location.\n* Newborns with CH who have thyroid imaging performed (thyroid ultrasound or technetium scan) at diagnosis.\n\nExclusion Criteria:\n\n* Newborns who do not have CH.\n* Newborns with CH who have not had thyroid imaging performed at diagnosis.'}, 'identificationModule': {'nctId': 'NCT02374593', 'briefTitle': 'Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Targeted Levothyroxine Dosing in Infants With Congenital Hypothyroidism', 'orgStudyIdInfo': {'id': '1401199401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Targeted dosing', 'description': 'Patients in this arm will receive targeted levothyroxine dosing based on thyroid anatomy on ultrasound as follows: 10 mcg/kg for normal gland, 12 mcg/kg for ectopic gland, 15 mcg/kg for athyreosis.', 'interventionNames': ['Drug: Levothyroxine', 'Device: Ultrasound']}], 'interventions': [{'name': 'Levothyroxine', 'type': 'DRUG', 'description': 'Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.', 'armGroupLabels': ['Targeted dosing']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'armGroupLabels': ['Targeted dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Erica Eugster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erica Eugster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Pediatric Endocrinologist', 'investigatorFullName': 'Erica Eugster', 'investigatorAffiliation': 'Indiana University'}}}}