Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01779817
Recruitment Status : Unknown
Verified June 2018 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : January 30, 2013
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment 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

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).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy
Study Start Date : February 2013
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ]

Secondary Outcome Measures :
  1. Score of the Achenbach Child Behavior Checklist [ Time Frame: within the first 30 days after inclusion of the patient ]
  2. Score of the conners scale [ Time Frame: within the first 30 days after inclusion of the patient ]
  3. Score of the Wechsler Intelligence Scale for Children (WISC-IV) [ Time Frame: within the first 30 days after inclusion of the patient ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779817


Contacts
Layout table for location contacts
Contact: Natacha BOUHOURS-NOUET NaBouhours-Nouet@chu-angers.fr

Locations
Layout table for location information
France
University Hospital of Amiens Recruiting
Amiens, France
Contact: RACHEL DESAILLOUD       Desailloud.Rachel@chu-amiens.fr   
Principal Investigator: RACHEL DESAILLOUD         
Sub-Investigator: HELENE Bony-Trifunovic         
Sub-Investigator: KARINE Braun         
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 Recruiting
Bron, France, 69677
Contact: Claire BOURNAUD       claire.bournaud@chu-lyon.fr   
Principal Investigator: Claire BOURNAUD         
Principal Investigator: Marc NICOLINO         
Sub-Investigator: Françoise BORSON-CHAZOT         
University Hospital of Kremlin Bicetre Recruiting
Le Kremlin Bicetre, France, 94275
Contact: Claire BOUVATTIER       claire.bouvattier@bct.aphp.fr   
Principal Investigator: Claire BOUVATTIER         
Principal Investigator: Philippe CHANSON         
University Hospital of Lille Active, not recruiting
Lille, France
University Hospital of Marseille Active, not recruiting
Marseille, France
University Hospital of Nantes Recruiting
Nantes, France, 44093
Contact: Delphine DRUI       delphine.drui@chu-nantes.fr   
Principal Investigator: Delphine DRUI         
Hospital of Saint Antoine Recruiting
Paris, France, 75012
Contact: Sophie CHRISTIN-MAITRE       sophie.christin-maitre@sat.aphp.fr   
Principal Investigator: Sophie CHRISTIN-MAITRE         
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
Layout table for investigator information
Principal Investigator: Natacha BOUHOURS-NOUET UNIVERSITY HOSPITAL OF ANGERS
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01779817    
Other Study ID Numbers: PHRC 2011-01
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases