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

• Status: Completed
• Trial end date: 2017-12-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Jerome Lejeune
• Collaborators: AnticipSante; Ascopharm Groupe Novasco; BIOMNIS; Central Hospital, Nancy, France; Effi-stat; Hôpital Cochin; Inserm U954 (Nancy); LC2; University of Paris 5 - Rene Descartes
• Treatments: Folic Acid; Hormones; Leucovorin; Levoleucovorin

Criteria

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)