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Evaluation of long term risk-benefit profile of levothyroxin treatment in children with congenital hypothyroidism:influence of initial levothyroxine dose on neurodevelopment, growth, cardiovascular and scheletal outcomes. - L-T4 dose and long-term outcome in CH children

Evaluation of long term risk-benefit profile of levothyroxin treatment in children with congenital hypothyroidism:influence of initial levothyroxine dose on neurodevelopment, growth, cardiovascular and scheletal outcomes. - L-T4 dose and long-term outcome in CH children

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-023481-41-IT
Enrollment
Unknown
Registered
2011-02-16
Start date
2011-02-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital hypothyroidism MedDRA version: 9.1 Level: LLT Classification code 10021115

Interventions

Pharmaceutical Form: Soluble tablet INN or Proposed INN: Levothyroxine sodium Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50-

Sponsors

UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Criteria for the inclusion in the study will be the following: - CH diagnosed by neonatal screening program - Age less than 30 days at diagnosis of CH - TSH value at confirmatory diagnosis above 30 mU/l - Caucasian ethnicity Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria will be: - Prematurity - Major congenital malformations - Neonatal diseases - Cromosomopathies - Known maternal thyroid diseases

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective of this randomised controlled trail is to evaluate the long term risk-benefit profile of long term treatment of two different initials tratment schemes with L-T4 on the neurodevelopmental and auxological outcomes in CH, diagnosed by neonatal screening.;Secondary Objective: The secondary objective of the study is to evaluate the role of other factors that, in addition to the initial L-T4 therapy,can influence long-term neurodevelopmental and auxological outcomes as well as the cardiovascular system and bone metabolism outcomes in children with CH.;Primary end point(s): To find the best dose of initial thyroid hormone replacement to assure the best long-term developmental outcome which is the primary goal of the early diagnosis and treatment of children with congenital hypothyroidism, without any adverse effects on auxological, cardiovascular and skeletal outcomes.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026