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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01779817
First received: January 28, 2013
Last updated: April 17, 2015
Last verified: April 2015
  Purpose
  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).

Condition Intervention Phase
Hyperthyroid
Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score of the Achenbach Child Behavior Checklist [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]
  • Score of the conners scale [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]
  • Score of the Wechsler Intelligence Scale for Children (WISC-IV) [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: February 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
child born to hyperthyroid mother during pregnancy
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
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
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

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

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779817

Contacts
Contact: Natacha BOUHOURS-NOUET NaBouhours-Nouet@chu-angers.fr

Locations
France
University Hospital of Angers Recruiting
Angers, France, 49000
Contact: Natacha BOUHOURS-NOUET       NaBouhours-Nouet@chu-angers.fr   
Principal Investigator: Frédéric ILLOUZ         
Sub-Investigator: Régis COUTANT         
Sub-Investigator: Patrice RODIEN         
Principal Investigator: Natacha BOUHOURS-NOUET         
Civil Hospices of Lyon Active, not recruiting
Bron, France, 69677
University Hospital of Kremlin Bicetre Active, not recruiting
Le Kremlin Bicetre, France, 94275
University Hospital of Nantes Recruiting
Nantes, France, 44093
Contact: Delphine DRUI       delphine.drui@chu-nantes.fr   
Principal Investigator: Delphine DRUI         
Hospital of Saint Antoine Active, not recruiting
Paris, France, 75012
University Hospital of Cochin Active, not recruiting
Paris, France, 75014
University Hospital of Poitiers Recruiting
Poitiers, France, 86021
Contact: Samy HADJADJ       s.hadjadj@chu-poitiers.fr   
Principal Investigator: Samy HADJADJ         
Sub-Investigator: Xavier PIGUEL         
University Hospital of Reims Active, not recruiting
Reims, France, 51092
University Hospital of Strasbourg Active, not recruiting
Strasbourg, France
University Hospital of Toulouse Active, not recruiting
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Natacha BOUHOURS-NOUET UNIVERSITY HOSPITAL OF ANGERS
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01779817     History of Changes
Other Study ID Numbers: PHRC 2011-01
Study First Received: January 28, 2013
Last Updated: April 17, 2015
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Hyperthyroidism
Endocrine System Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on August 30, 2015