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ENROLLING BY INVITATION
NCT06864039
NA

Quality of Life and Long-term Outcome of Adequately Treated Congenital Hypothyroidism

Sponsor: Federico II University

View on ClinicalTrials.gov

Summary

The primary objective of this observational study is the evaluation of the quality of life and long-term outccome of young-adult patients with congenital hypothyroidism diagnosed by neonatal screening receiving replacement treatment with levothyroxine. The secondary objective is to relate the results to the form of hypothyroidism, the initial dose of L-T4, treatment adherence and genetics

Official title: Quality of Life and Long-term Outcome of Transition-age Patients With Congenital Hypothyroidism Diagnosed by Newborn Screening and Adequately Treated

Key Details

Gender

All

Age Range

16 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-09-06

Completion Date

2025-12-31

Last Updated

2025-03-07

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

SF36 test

Assessment of quality of life by administering the SF36 test

DIAGNOSTIC_TEST

WAIS IV test

Assessment of cognitive abilities by administering the WAIS IV test

DIAGNOSTIC_TEST

SCL-90 psychopathological screening questionnaire

Assessment of any psychopathological conditions by means of the SCL-90 psychopathological screening questionnaire

DIAGNOSTIC_TEST

CBCL questionnaire

For patients up to 18 years of age: CBCL questionnaire to be administered to parents to describe the patient's behavior

DIAGNOSTIC_TEST

bioimpedance analysis

Assessment of body composition by performing bioimpedance analysis

Locations (1)

Pediatric Endocrinology Program, Department of the Mother and the Child, University Federico II of Naples

Naples, Italy