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

Institut Jerome Lejeune

Status and phase

Completed

Phase 3

Conditions

Down Syndrome

Treatments

Drug: thyroid hormone and folinic acid

Study type

Interventional

Funder types

Other

Identifiers

IJL-AFHT-TH10

Details and patient eligibility

About

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.

Enrollment

175 patients

Sex

All

Ages

6 to 18 months old

Volunteers

No Healthy Volunteers

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)