drugset / Trial / NCT07625722

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

NCT07625722

Not yet recruiting 106 enrolled Shandong Provincial Hospital
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2026-06-20
Primary completion
2027-06-20
Completion
2029-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Levothyroxine Other / unclassified 8 ug/kg Oral