NCT07625722尚未招募不适用
Growth and Neurodevelopmental Outcomes at Two Years of Age After Postnatal Thyroid Hormone Supplementation in SGA Infants With Birth Weight <1500g and TSH 6-20 mIU/ml
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 106
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Presence of major congenital malformations of vital organs or known chromosomal/genetic disorders;
- •History of maternal thyroid disease or maternal use of thyroid-related medications.
研究者
Yonghui Yu
Chief physician
Shandong Provincial Hospital
研究点 (1)
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