Cognitive and motor development, nerve function, somatic growth and (pubertal) development, and (spontaneous) thyroid function in 10,5 years old Down syndrome children after thyroxine or placebo treatment until the age of 2 years.

Cognitive and motor development, nerve function, somatic growth and (pubertal) development, and (spontaneous) thyroid function in 10,5 years old Down syndrome children after thyroxine or placebo treatment until the age of 2 years. - Neurodevelopment in Down syndrome after thyroxine treatment early in life

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33051

Enrollment

181

Registered

2009-11-27

Start date

2009-11-15

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

"Down syndrome" en "Down's syndrome"

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: See item D3.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Cognitive development determined with the Snijders-Oomen Non-Verbale Intelligentietest-Revisie or with the mental scale of the Dutch second version of the Bayley Scales of Infant Development (BSID-II, in children with a severe delay).	—

Secondary

Measure	Time frame
Gross Motor development determined with the Movement Assessment Battery for Children or with the psychomotor scale of the BSID-II (in children with a developmental age lower than 3 years). Fine Motor Development determined with the Beery test of Visuo-Motor Integration. Processing Speed measured with the baseline speed computer task of the Amsterdamse Neuropsychologische Testbatterij. Behavioural development determined with the Vragenlijst omtrent ontwikkeling en gedrag bij kinderen. Nerve function (conduction velocity) determined with a somatosensory evoked potentials test. Somatic growth and (pubertal) development determined with physical examination. (Spontaneous) thyroid function determined with thyroid ultrasonography and laboratory tests.	—

Measure

Time frame

Gross Motor development determined with the *Movement Assessment Battery for Children* or with the psychomotor scale of the BSID-II (in children with a developmental age lower than 3 years). Fine Motor Development determined with the *Beery test of Visuo-Motor Integration*. Processing Speed measured with the baseline speed computer task of the *Amsterdamse Neuropsychologische Testbatterij*. Behavioural development determined with the *Vragenlijst omtrent ontwikkeling en gedrag bij kinderen*. Nerve function (conduction velocity) determined with a somatosensory evoked potentials test. Somatic growth and (pubertal) development determined with physical examination. (Spontaneous) thyroid function determined with thyroid ultrasonography and laboratory tests.

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Countries

Netherlands

Outcome results