About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preterm infants born Small for Gestational Age (SGA) with a birth weight < 1500g;
Admitted to a participating Neonatal Intensive Care Unit (NICU) within 7 days of birth;
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/mL;
Written informed consent obtained from the parents.
Disqualifiers
Diagnosis of Congenital Hypothyroidism (CH) with serum TSH > 20 mIU/mL within the first 2 weeks of life and receiving L-T4 treatment;
Persistent serum TSH < 6 mIU/mL throughout the first 2 weeks;
Elevated thyroid hormone levels(T3, T4, FT3, or FT4) above the reference range within the first 2 weeks;
Diagnosis of Grade III or IV Intraventricular Hemorrhage (IVH) within the first 2 weeks of life;
Trial design
Parallel
Treatments tested in this trial
Levothyroxine Sodium (LT4) Tablets
DrugThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Cognitive function evaluated by Bayley-IV
Motor function evaluated by Bayley-IV
Language function evaluated by Bayley-IV
Social-Emotional evaluated by Bayley-IV
Secondary outcomes
the incidence of neonatal morbidities (EUGR、PNAC、MBDP、Moderate to severe BPD、Stage III or higher ROP)during the initial hospitalization
All-cause Mortality
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: