[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638001":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":29,"responsibleParty":45,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":56,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shandong Provincial Hospital","OTHER_GOV",[8,12],{"label":9,"type":10,"description":11,"interventionNames":11},"control group","NO_INTERVENTION",null,{"label":13,"type":14,"description":11,"interventionNames":15},"intervention group","EXPERIMENTAL",[16],"Drug: Levothyroxine Sodium (LT4) Tablets",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Levothyroxine Sodium (LT4) Tablets","The intervention group will receive oral levothyroxine (L-T4) initiated on postnatal day 14 at a starting dose of 8 ug\u002Fkg\u002Fday. Thyroid function will be monitored every 2-4 weeks until 36 weeks postmenstrual age or hospital discharge, with subsequent follow-up at corrected ages of 40 weeks, 3, 6, 12, 18, and 24 months. The L-T4 dosage will be dynamically titrated to achieve therapeutic targets of TSH \\\u003C 5 mIU\u002FL and FT3\u002FFT4 levels within the upper 50% of the age-specific reference range. Treatment will be discontinued if therapeutic targets are sustained at a dosage below 2 ug\u002Fkg\u002Fday or if FT3\u002FFT4 levels exceed the upper limit of normal.",[13],[24],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Yonghui Yu","CONTACT","+8615168887236","alice20402@126.com",[30],{"facility":31,"status":11,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Shandong Provincial Hospital Affiliated to Shandong First Medical University","Jinan","Shandong","250021","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.99722,36.66833,{"lat":41,"lon":40},[44],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},{"type":46,"investigatorFullName":25,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Chief physician","100638001","thyroxine-supplementation-in-small-for-gestational-age-sga-infants-with-birth-weight-1500g-and-tsh-6-20-miuml-100638001",false,"NCT07625722","Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight \u003C1500g and TSH 6-20 mIU\u002Fml","Growth and Neurodevelopmental Outcomes at Two Years of Age After Postnatal Thyroid Hormone Supplementation in SGA Infants With Birth Weight \u003C1500g and TSH 6-20 mIU\u002Fml","Inclusion Criteria:\n\n* Preterm infants born Small for Gestational Age (SGA) with a birth weight \\\u003C 1500g；\n* Admitted to a participating Neonatal Intensive Care Unit (NICU) within 7 days of birth；\n* Serum concentrations of TSH, FT4, and FT3 are measured weekly during the first and second weeks of life，any single TSH measurement during this period is between 6 and 20 mIU\u002FmL；\n* Written informed consent obtained from the parents.\n\nExclusion Criteria:\n\n* Diagnosis of Congenital Hypothyroidism (CH) with serum TSH \\> 20 mIU\u002FmL within the first 2 weeks of life and receiving L-T4 treatment;\n* Persistent serum TSH \\\u003C 6 mIU\u002FmL throughout the first 2 weeks;\n* Elevated thyroid hormone levels(T3, T4, FT3, or FT4) above the reference range within the first 2 weeks;\n* Diagnosis of Grade III or IV Intraventricular Hemorrhage (IVH) within the first 2 weeks of life;\n* Presence of major congenital malformations of vital organs or known chromosomal\u002Fgenetic disorders;\n* History of maternal thyroid disease or maternal use of thyroid-related medications.","ALL","2 Weeks",{"count":58,"type":59},106,"ESTIMATED","INTERVENTIONAL",[62],"NA","The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug\u002Fkg\u002Fd, initiated in the second week of life, improves physical growth and neurodevelopmental outcomes at 2 years of corrected age in Small for Gestational Age (SGA) infants with birth weights \\\u003C 1500g and TSH levels between 6 and 20 mIU\u002Fml. Preterm infants in the intervention group will receive 8 ug\u002Fkg\u002Fd of L-T4, while the control group will receive no supplementation. Physical growth will be assessed through height, weight, and head circumference, while neurodevelopmental status will be evaluated using the Bayley-IV scales and cranial MRI imaging findings.",[65,66,67,68],"Thyroid Function","Preterm","SGA and Growth","Neurodevelopment Outcome","NOT_YET_RECRUITING","2026-05-29",{"date":72,"type":73},"2026-06-04","ACTUAL",{"date":75,"type":59},"2026-06-20",{"date":77,"type":59},"2029-06-20",{"name":5,"class":6},1]