Influence of Initial Levothyroxine Dose on Neurodevelopmental and Growth Outcomes in Congenital Hypothyroidism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2018-05-31

Brief Summary

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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 outcomes in children with congenital hypothyroidism, diagnosed by neonatal screening in order to find the best dose of initial thyroid hormone replacement to assure the best long-term developmental outcome without any adverse effects on auxological, cardiovascular and skeletal outcomes. 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.

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Detailed Description

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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 initial replacement dose of 10-12.5 mcg/kg/die and Group B received an initial replacement dose of 12.6-15 mcg/kg/die. The adequacy of treatment were monitored closely by clinical evaluation and regular measurement of FT4 and TSH. Cognitive development were evaluated through the Griffiths Mental Development Scales at the the age of 2 yeas. Cognitive and behavioural assessment at the age of 4 years were performed using the Wechsler Preschool and Primary scale of Intelligence. Growth were evaluate at the enrolment and at each visit. Skeletal maturation were evaluated at diagnosis and at the age of 1 and 4 years. At the age of 4 years a quantitative ultrasound measurements and cardiovascular evaluation were performed.

Conditions

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Congenital Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Children were randomly assigned to receive an initial L-T4 dose of 10-12.5 μg/kg/day (Group A) or 12.6-15 μg/kg/day (Group B). Randomization was designed according to a block scheme (8 blocks of 6 patients and 6 blocks of 4 patients which were randomly alternated) which guaranteed the frequency balance in the two groups during the enrolment without altering the causality of the assignment. Random allocation sequence was generated using the function sample in R statistical platform.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10-12.5 μg/kg/day of L-T4

Children with congenital hypothyroidism who received an initial L-T4 dose of 10-12.5 μg/kg/day.

Group Type ACTIVE_COMPARATOR

Levothyroxin

Intervention Type DRUG

Congenital hypothyroidism children received two different doses of levothyroxin within the recommended range to evaluate any differences in long-term outcomes.

12.6-15 μg/kg/day of L-T4

Children with congenital hypothyroidism who received an initial L-T4 dose of 12.6-15 μg/kg/day.

Group Type ACTIVE_COMPARATOR

Levothyroxin

Intervention Type DRUG

Congenital hypothyroidism children received two different doses of levothyroxin within the recommended range to evaluate any differences in long-term outcomes.

Interventions

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Levothyroxin

Congenital hypothyroidism children received two different doses of levothyroxin within the recommended range to evaluate any differences in long-term outcomes.

Intervention Type DRUG

Other Intervention Names

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L-T4

Eligibility Criteria

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Inclusion Criteria

* 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