Clinical Trial

Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight <1500g and TSH 6-20 mIU/ml

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Summary
The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug/kg/d, 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 \< 1500g and TSH levels between 6 and 20 mIU/ml. Preterm infants in the intervention group will receive 8 ug/kg/d 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.
Trial Details
NCT Number NCT07625722
Lead Sponsor Shandong Provincial Hospital
Conditions Thyroid Function, Preterm, SGA and Growth, Neurodevelopment Outcome
Enrollment 106 participants
Start Date 2026-06-20
Primary Completion 2027-06-20 (estimated)
Study Completion 2029-06-20 (estimated)
Updated on ClinicalTrials.gov 2026-06-04