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临床试验/NCT06051279
NCT06051279尚未招募不适用

Pattern of Congenital Hypothyroidism in Newborns in Sidi-Galal Clinic Assiut Governorate.

Assiut University0 个研究点目标入组 300 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
Pattern of congenital hypothyroidism in newborns after positive newborn screening results.

研究概览

简要总结

  1. Study the pattern of congenital hypothyroidism in newborns after positive newborn screening results.
  2. Assess the characteristics of the cases (permanent congenital hypothyroidism and transient neonatal hyperthyrotopinemia).

详细描述

Thyroid hormone is essential for normal somatic growth and neurological development in infants and children. Deficiency of thyroid hormone in the first 2 years of life results in congenital hypothyroidism (CH). CH manifests by mental retardation and growth retardation in newborn.

Newborn screening (NS) for CH aims to early diagnosis and treatment of hypothyroidism. CH occurs about one in 3000-4000 infants . CH is suspected in neonatal screening when capillary thyroid-stimulating hormone (TSH) concentrations are elevated (>15 mU/L in Germany). The diagnosis is confirmed by measuring venous TSH and free thyroxine levels (FT4) concentrations before the start of treatment.

CH can be classified into permanent or transient congenital hypothyroidism (TCH). While CH is a persistent deficiency of thyroid hormones that requires lifelong treatment, TCH is a temporary deficiency that reverts to normal concentrations with proper medical management, usually during the first few months of life and not after the age of 3 years.

Transient neonatal hyperthyrotropinemia (TNH) is defined as temporary postnatal elevation of TSH levels (10 mIU/L-20 mIU/L) with normal FT4 levels but TSH returning to normal (<10 mIU/L) when measured at 14 d of life. It is important to recognize TNH as these newborns have a higher risk of developing permanent hypothyroidism with repercussion on developmental status. Thus, we aimed at evaluating the neonatal and maternal factors associated with TNH . So that, identifying these factors may be considered as an appropriate strategy to prevent these possible disorders. There is a gap in studying the prevalence and the predictors of transient neonatal hyperthyrotropinemia particularly in Assiut Governorate.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
15 Days 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • For the case series study: all positive newborns cases with raised TSH level (the confirmed raised TSH cases after thyroid hormone screening) within one month after birth will be taken during one year.
  • For the secondary outcome to study the predictors of permanent congenital hypothyroidism and transient neonatal hyperthyrotropinemia, control group with matched age and gender with normal TSH at birth according to the neonatal TSH screening will be taken. Matched normal neonates will be selected to be compared with permanent congenital hypothyroidism cases and transient neonatal hyperthrotropinemia cases.

排除标准

  • Cases that refused to participate in research.
  • Cases that missed for follow up.

结局指标

主要结局

Pattern of congenital hypothyroidism in newborns after positive newborn screening results.

时间窗: through study completion, an average of 1 year

The data will be collected from the records of laboratory investigation to assess the pattern of congenital hypothyroidism

次要结局

  • Predictors of permanent congenital hypothyroidism and transient neonatal hyperthyrotropinemia as neonatal, obstateric and maternal factors.(through study completion, an average of 1 year)
  • Characteristics of studied newborns in all types of congenital hypothyroidism in Sidi-Galal clinic as in feeding, nutritional status and growth parameters.(through study completion, an average of 1 year)

研究者

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

Fatma El Zahra Fathy Mohamed Abdelhady

resident physician at family medicine department

Assiut University

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