An interventional study of Levothyroxine Sodium (LT4) Tablets in Thyroid Function, Preterm and SGA and Growth, sponsored by Shandong Provincial Hospital. Not yet recruiting at 1 site in China. Open to participants aged 2 Weeks to 2 Weeks. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Shandong Provincial Hospital · Not applicable, Interventional, and Prevention
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.
2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 106 is above the median of 84 across 1,688 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
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/kg/day. 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 \< 5 mIU/L and FT3/FT4 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/kg/day or if FT3/FT4 levels exceed the upper limit of normal.
Cognitive function evaluated by Bayley-IV
Time frame: At 24 months corrected age
Motor function evaluated by Bayley-IV
Time frame: At 24 months corrected age
Language function evaluated by Bayley-IV
Time frame: At 24 months corrected age
Social-Emotional evaluated by Bayley-IV
Time frame: At 24 months corrected age
Adaptive behavior evaluated by Bayley-IV
Time frame: At 24 months corrected age
Body length（cm）assessed by the WHO 0-5 years Child Growth Standards.
Time frame: At 24 months corrected age
Head circumference（cm）assessed by the WHO 0-5 years Child Growth Standards.
Time frame: At 24 months corrected age
Weight（kg）assessed by the WHO 0-5 years Child Growth Standards.
Time frame: At 24 months corrected age
the incidence of neonatal morbidities （EUGR、PNAC、MBDP、Moderate to severe BPD、Stage III or higher ROP）during the initial hospitalization
Time frame: at 36 weeks of postmenstrual age
All-cause Mortality
Time frame: At 24 months corrected age
Plan to share: No
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Shandong Provincial Hospital