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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | ||
| intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine Sodium (LT4) Tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function evaluated by Bayley-IV | At 24 months corrected age | |
| Motor function evaluated by Bayley-IV | At 24 months corrected age | |
| Language function evaluated by Bayley-IV | At 24 months corrected age | |
| Social-Emotional evaluated by Bayley-IV | At 24 months corrected age | |
| Adaptive behavior evaluated by Bayley-IV | At 24 months corrected age | |
| Body length(cm)assessed by the WHO 0-5 years Child Growth Standards. | At 24 months corrected age | |
| Head circumference(cm)assessed by the WHO 0-5 years Child Growth Standards. | At 24 months corrected age | |
| Weight(kg)assessed by the WHO 0-5 years Child Growth Standards. | At 24 months corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of neonatal morbidities (EUGR、PNAC、MBDP、Moderate to severe BPD、Stage III or higher ROP)during the initial hospitalization | at 36 weeks of postmenstrual age | |
| All-cause Mortality | At 24 months corrected age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yonghui Yu | Contact | +8615168887236 | alice20402@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | 250021 | China |
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|
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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