Clinical trial NCT01779817: Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy
Official title: Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperthyroid
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2013-01-30
Enrollment: 252
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Scores of global development Quotient (WISC-R)
timeFrame: within the first 30 days after inclusion of the patient
Secondary outcomes:
measure: Score of the Achenbach Child Behavior Checklist
timeFrame: within the first 30 days after inclusion of the patient
measure: Score of the conners scale
timeFrame: within the first 30 days after inclusion of the patient
measure: Score of the Wechsler Intelligence Scale for Children (WISC-IV)
timeFrame: within the first 30 days after inclusion of the patient
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital of Amiens
city: Angers
country: France
facility: University Hospital of Angers
city: Bron
country: France
facility: Civil Hospices of Lyon
city: Le Kremlin Bicetre
country: France
facility: University Hospital of Kremlin Bicetre
city: Lille
country: France
facility: University Hospital of Lille
city: Marseille
country: France
facility: University Hospital of Marseille
city: Nantes
country: France
facility: University Hospital of Nantes
city: Paris
country: France
facility: Hospital of Saint Antoine
city: Paris
country: France
facility: University Hospital of Cochin
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Reims
country: France
facility: University Hospital of Reims
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: UNIVERSITY HOSPITAL OF ANGERS
name: Natacha BOUHOURS-NOUET
role: PRINCIPAL_INVESTIGATOR
References: