Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children

Institut Jerome Lejeune175 enrolled

Overview

Evaluation of the following in very young children with Down syndrome: * the efficacy of systematic treatment with L-thyroxine at controlled doses (clinically and by ultrasensitive thyreostimulating hormone (TSH) assay), * the efficacy of systematic folinic acid treatment at a dose of 1 mg/kg/o.i.d, * any interaction between these two treatments.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

175

Conditions

Down Syndrome

Interventions

thyroid hormone and folinic acidDRUG

thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Months

Medical Language ↔ Plain English

Inclusion Criteria: * patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21 * patient having undergone a cardiac ultrasound not demonstrating any severe heart disease * patient aged 6 to 18 months at inclusion Exclusion Criteria: * congenital hypothyroidism * hypothyroidism demonstrated by laboratory tests (TSH \> 7mUI/l) * presenting or having presented hyperthyroidism * presenting or having presented leukaemia * presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease * presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis) * presenting severe heart disease on cardiac ultrasound, with haemodynamic effects * presenting non-controlled cardiac arrhythmia * Apgar \< 7 to 5 min at birth * Gestational age \< 231 days (33 gestation weeks)

Locations (1)

Institut Jerome Lejeune

Paris, France

Outcomes

Primary Outcomes

GMDS (Griffiths Mental Development Scale)

GMDS for testing and estimate babies psychomotor development from birth to 2 years trough six subscales : Locomotor, Personal-social, Hearing and language, Eye-Hand coordination, Performance.Sub- and General Quotients (GDQ) standard score are based on a mean of 100 and a standard deviation of 16. For children with delayed development, which is the case for children with Down Syndrome, Quotient tables could be not used because sub- and General quotient floors at 50. For each subscale, a raw score was derived from the contributing items. Total raw score was obtained by adding subscale raw scores. Sum of all subscale raw scores was converted into a development age using correspondence table. Subscale and global development quotients were computed by dividing the development age by the chronological age multiplied by 100. For preterm infants, chronological age was corrected taking into account the gestational term. Higher QD's scores show a better psychomotor development outcome

Time frame: 12 months

Secondary Outcomes

BL (Brunet Lezine Revised Scale)

BL includes 4 subscales : Locomotor, Coordination, Language, Sociability. Subscale and global developpemental quotients were computed by dividing the developpemental age by the chronological age multiplied by 100. This kind of formula do not give a min-max outcome. Higher QD's scores show a better psychomotor developpement outcome.

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.