Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight <1500g and TSH 6-20 mIU/ml
2026年5月29日 更新者：Yonghui Yu、Shandong Provincial Hospital
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
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.
研究概览
研究类型
介入性
注册 (估计的)
106
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yonghui Yu
- 电话号码：+8615168887236
- 邮箱：alice20402@126.com
学习地点
-
-
Shandong
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Jinan、Shandong、中国、250021
- Shandong Provincial Hospital Affiliated to Shandong First Medical University
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接触：
- Yonghui Yu
- 电话号码：+8615168887236
- 邮箱：alice20402@126.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制组
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实验性的：干预组
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Cognitive function evaluated by Bayley-IV
大体时间：At 24 months corrected age
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At 24 months corrected age
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Motor function evaluated by Bayley-IV
大体时间：At 24 months corrected age
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At 24 months corrected age
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Language function evaluated by Bayley-IV
大体时间：At 24 months corrected age
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At 24 months corrected age
|
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Social-Emotional evaluated by Bayley-IV
大体时间：At 24 months corrected age
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At 24 months corrected age
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Adaptive behavior evaluated by Bayley-IV
大体时间：At 24 months corrected age
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At 24 months corrected age
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Body length（cm）assessed by the WHO 0-5 years Child Growth Standards.
大体时间：At 24 months corrected age
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At 24 months corrected age
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Head circumference（cm）assessed by the WHO 0-5 years Child Growth Standards.
大体时间：At 24 months corrected age
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At 24 months corrected age
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Weight（kg）assessed by the WHO 0-5 years Child Growth Standards.
大体时间：At 24 months corrected age
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At 24 months corrected age
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
the incidence of neonatal morbidities （EUGR、PNAC、MBDP、Moderate to severe BPD、Stage III or higher ROP）during the initial hospitalization
大体时间：at 36 weeks of postmenstrual age
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at 36 weeks of postmenstrual age
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All-cause Mortality
大体时间：At 24 months corrected age
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At 24 months corrected age
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月20日
初级完成 (估计的)
2027年6月20日
研究完成 (估计的)
2029年6月20日
研究注册日期
首次提交
2026年5月13日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年5月29日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.