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临床试验/NCT04734457
NCT04734457Unknown不适用

Final Height in Patients With Congenital Hypothyroidism Diagnosed by Neonatal Screening

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月2日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Assessment of change of Final Height in patients with Congenital Hypothyroidism diagnosed by neonatal screening

研究概览

简要总结

The aim of this study is to evaluate longitudinal growth and final height in patients with Congenital Hypothyroidism detected by neonatal screening and factors affecting it.

详细描述

Linear growth and final height are reported as rather normal in patients with CH diagnosed through the screening and the target height is the most important factor determining linear growth. Data on final height in patients with CH suggest that adult height is significantly correlated with parental height and the mean L-Thyroxine daily dose administered over the first 6 months of treatment. The lowest recommended dose during this period is 8.5μg/kg/day. Periodical adjustments of L-Thyroxine daily dose should be guided by clinical observation and serum free T4 levels.

To our knowledge this is the first study from our center to assess final height in patients with congenital hypothyroidism diagnosed through the Egyptian neonatal screening program.

A complex network of endocrine signals stimulates the process of longitudinal growth including growth hormone, insulin-like growth factor-1, glucocorticoids, thyroid hormone, estrogen, androgens, vitamin D and leptin.

Thyroid hormones are essential for development and normal bone growth. Biochemical studies have shown that thyroid hormones can affect the expression of various bone markers in the serum, reflecting changes in bone remodeling which involves both osteoblastic and osteoclastic activities.

Thyroid hormones act through chondrocytes bearing thyroid hormone receptors (TRs) to modulate growth plate proliferation, differentiation and vascular invasion. Several mechanisms mediate these functions including direct action on the chondrocytes, osteoblasts and mast cells. It also works through interaction with other hormones and growth factors acting in endocrine, paracrine and autocrine fashions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients having a documented history of CH diagnosed by Egyptian neonatal screening program.
  • Patients receiving L-thyroxine (L-T4) since the diagnosis is established.

排除标准

  • Patients who are non-compliant on L-thyroxine (L-T4) and failed to follow up at the clinic on regular basis.
  • Patients who were missed from diagnosis by neonatal screening.
  • Patients with associated hormonal disorders affecting same parameters concerned in the study.

结局指标

主要结局

Assessment of change of Final Height in patients with Congenital Hypothyroidism diagnosed by neonatal screening

时间窗: Since the diagnosis is established by neonatal screening during first week of life height will be assessed every 6 months with follow up throughout the study period until the study subject reaches an average of 18 years of age( final height reached).

The investigators assess the effect of early diagnosis and early levothyroxine start on the change in longitudinal growth in patients with Congenital Hypothyroidism.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Nader

Principal Investigator

Ain Shams University

研究点 (1)

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