Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy (EDIEMHYPER)

University Hospital, Angers

Status and phase: Unknown; Phase 4

Conditions: Hyperthyroid

Treatments: Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Study type: Interventional

Funder types: Other

Identifiers

NCT01779817

PHRC 2011-01

Details and patient eligibility

About

1. MAIN OBJECTIVE :

   To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual development of the child from 6 to 9 years

2. SECONDARY OBJECTIVES :

   1. To assess the consequences of a maternal hyperthyroïd during pregnancy on the capacities of attention, learning process and the degree of hyperactivity of the child from 6 to 9 years.

   2. To study if it exist differences of intellectual development, capacities of attention, learning process, and degree of hyperactivity in the child from 6 to 9 years, born to hyperthyroid mother during pregnancy, according to:

      • the etiology of the maternal hyperthyroïd (transitory gestation hyperthyroid versus disease of Basedow),
      • the use or not of a anti-thyroid treatment,
      • the rate of TSH néonatal (measured with the blotter by tracking with J3 at all the new born ones).

Full description

1. INCLUSION CRITERIA :

   • Old from 6 to 9 years included
   • Age of gestation between ≥37 and <41 weeks of amenorrhoea
   • Born from a mono-foetale pregnancy
   • Euthyroïd at the time of the entry in the study
   • Provided education for at the elementary school on a level adapted to its age

2. NON INCLUSION CRITERIA :

   • Presenting a congenital hypothyroïd or a known thyroid dysfonction at the time of the entry in the study
   • Carrier of a chronic pathology (organic or psychological) or malformative severe
   • Presenting an antecedent of Deficit of the Attention-Hyperactivity to the 1st degree

3. EXCLUSION CRITERIA :

   o Discovered of a thyroid dysfonction at the time of the entry in the study

4. STRATEGIES / PROCEDURES :

Multicentric, comparative study of a troop of child born to hyperthyroïd mothers during pregnancy (children exposed to the maternal hyperthyroïd) and children born to euthyroïd mothers during pregnancy (nonexposed children with the maternal hyperthyroïd).

• 1st part of the study: Retrospective analyze of the files of symptomatic hyperthyroid mothers during pregnancy.
• 2nd part of the study: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. The exposed children (born to hyperthyroïd mothers during pregnancy) will be compared with nonexposed children (born to euthyroïd mothers during pregnancy).

Enrollment: 252 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria:

   A-For the child born to hyperthyroid mother during pregnancy :

   oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age

   B-For hyperthyroid mother during pregnancy :

   oHyperthyroïd during pregnancy (transitory gestation hyperthyroid or disease of Basedow) oEuthyroïd at the time of the entry in the study

   C-For the child born to euthyroid mother during pregnancy :

   oOld from 6 to 9 years included oAge of gestation between ≥37 and <41 weeks of amenorrhoea oBorn from a mono-foetale pregnancy oEuthyroïd at the time of the entry in the study oProvided education for at the elementary school on a level adapted to its age

   D-For euthyroid mother during pregnancy :

   Euthyroïd at the time of the entry in the study

2. Exclusion Criteria:

A-For the child born to hyperthyroid mother during pregnancy :

Discovered of a thyroid dysfonction at the time of the entry in the study

B-For hyperthyroid mother during pregnancy:

Discovered of a thyroid dysfonction at the time of the entry in the study

C-For the child born to euthyroid mother during pregnancy:

Discovered of a thyroid dysfonction at the time of the entry in the study

D-For euthyroid mother during pregnancy:

oDiscovered of a thyroid dysfonction at the time of the entry in the study oCarrying anti-TPO antibody at the time of the entry in the study

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 2 patient groups

child born to hyperthyroid mother during pregnancy

Other group

Description:

Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Treatment:

Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

child born to euthyroid mother during pregnancy

Other group

Description:

Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Treatment:

Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.