Status:
COMPLETED
Influence of Initial Levothyroxine Dose on Neurodevelopmental and Growth Outcomes in Congenital Hypothyroidism
Lead Sponsor:
Federico II University
Conditions:
Congenital Hypothyroidism
Eligibility:
All Genders
3-29 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to evaluate the risk-benefit profile of long-term treatment of two different initials treatment schemes with L-T4 on the neurodevelopmental and auxological outco...
Detailed Description
Seventy-two neonates detected by the neonatal screening program for congenital hypothyroidism were randomly assigned to receive one of the two initial L-T4 replacement dose: Group A received an initia...
Eligibility Criteria
Inclusion
- Congenital Hypothyroidism diagnosed by neonatal screening program
- Age less than 30 days at diagnosis
- TSH value at confirmatory diagnosis above 30 mU/l
- Caucasian ethnicity
Exclusion
- Prematurity
- Major congenital malformations
- Neonatal diseases
- Chromosomopathies
- Known maternal thyroid diseases
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05371262
Start Date
May 1 2011
End Date
May 1 2018
Last Update
May 12 2022
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