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临床试验/CTRI/2024/03/063631
CTRI/2024/03/063631已完成不适用

A study of incidence, clinical profile and etiology of congenital hypothyroidism in a tertiary care hospital.

Not applicable1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月11日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
To study incidence, clinical profile and etiology of congenital hypothyroidism in term newborns and clinical profile, etiology in children aged less than 5 years in whom congenital hypothyroidism is diagnosed at an age ≤ 1 year

研究概览

简要总结

In subgroup 1 , all term newborns admitted under neonatology will be screened for congenital hypothyroidism after 48 - 72 hours of life (standard treatment) (TSH based screening) .Diagnosis of congenital hypothyroidism will be entertained as per ISPAE 2018 criteria. After diagnosis is confirmed : USG neck , Tc 99 thyroid scan, hearing test will be done as per standard of care. Clinical profile of such newborns will be documented . In subgroup 2 , children aged < 5 years who are already diagnosed to have congenital hypothyroidism coming up for follow up will be studied. Patients will be included in the study only if their thyroid function test at the time of diagnosis satisfy ISPAE 2018 diagnostic criteria . Detailed history, age ,investigations at the time of diagnosis , type of congenital hypothyroidism , dose of thyroxine , growth ,development and other relevant information will be documented.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • 2 subgroups: Subgroup 1: All term newborns admitted under Department of Neonatology undergoing NBS for Congenital Hypothyroidism Subgroup 2: Children aged less than 5 years diagnosed with Congenital Hypothyroidism at an age ≤ 1 year at the Department of Paediatrics , Kasturba Medical College, Manipal.

排除标准

  • Children whose parents deny consent.

结局指标

主要结局

To study incidence, clinical profile and etiology of congenital hypothyroidism in term newborns and clinical profile, etiology in children aged less than 5 years in whom congenital hypothyroidism is diagnosed at an age ≤ 1 year

时间窗: At admission (48 -72 hours of life) for term newborns in subgroup 1 and at follow up clinical visit in subgroup 2

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Not applicable
申办方类型
Other [Not applicable]
责任方
Principal Investigator
主要研究者

Priyanka P

Kasturba Medical College,MAHE,Manipal-576104

研究点 (1)

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