Quality of Life and Long-term Outcome of Adequately Treated Congenital Hypothyroidism
Key facts
- Who runs it
- Federico II University
- Where
- Naples, ItalySee the site
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 150 people, planned
- Started
- 6 Sept 2024
- Planned end
- 31 Dec 2025
- Type of study
- Interventional
- Treatments tested
- SF36 test
- WAIS IV test
- SCL-90 psychopathological screening questionnaire
- CBCL questionnaire
- bioimpedance analysis
- Record updated
- 7 March 2025
Who can take part
- Age
- 16 years to 21 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Diagnosis of congenital hypothyroidism by neonatal screening
- Start of L-T4 therapy within the first month of life
- Confirmation of hypothyroidism condition upon reassessment of diagnosis
Who cannot take part
- other chronic diseases and/or genetic syndromes
- family history of neuropsychiatric pathology
- familial dyslipidemia
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 21 years old?
Where in Italy
- Pediatric Endocrinology Program, Department of the Mother and the Child, University Federico II of NaplesNaples, ItalyNo longer taking part
About the trial
What the trial wants to find out
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.
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The secondary objective is to relate the results to the form of hypothyroidism, the initial dose of L-T4, treatment adherence and genetics
The group in the trial
- Adolescents aged 16-21 years with congenital hypothyroidism diagnosed by newborn screeningOther group
A) Clinical assessment (Weight, Height, BMI, Waist and hip circumference, blood pressure) B) Assessment of body composition by performing bioimpedance analysis C) Assessment of quality of life by administering the SF36 test D) Assessment of cognitive abilities by administering the WAIS IV test E) Assessment of any psychopathological conditions by means of the SCL-90 psychopathological screening questionnaire F) For patients up to 18 years of age: CBCL questionnaire to be administered to parents to assess the patient's behavior
Treatment: SF36 test, WAIS IV test, SCL-90 psychopathological screening questionnaire, CBCL questionnaire, and bioimpedance analysis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Quality of Life and Long-term Outcome of Transition-age Patients With Congenital Hypothyroidism Diagnosed by Newborn Screening and Adequately Treated
- Fit questions
- Built from NCT06864039, who can take part
- Record updated
- 7 March 2025