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Clinical Trials/CTRI/2024/03/063631
CTRI/2024/03/063631
Completed
Not Applicable

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

Not applicable1 site in 1 country50 target enrollmentStarted: March 11, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
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

Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 5.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Children whose parents deny consent.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Not applicable(Not applicable)

Investigators

Sponsor Class
Other [Not applicable]
Responsible Party
Principal Investigator
Principal Investigator

Priyanka P

Kasturba Medical College,MAHE,Manipal-576104

Study Sites (1)

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