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Trial record 1 of 1 for:    NCT01779817
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Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy (EDIEMHYPER)

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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

Tracking Information
First Submitted Date  ICMJE January 28, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date June 15, 2018
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
  • Score of the Achenbach Child Behavior Checklist [ Time Frame: within the first 30 days after inclusion of the patient ]
  • Score of the conners scale [ Time Frame: within the first 30 days after inclusion of the patient ]
  • Score of the Wechsler Intelligence Scale for Children (WISC-IV) [ Time Frame: within the first 30 days after inclusion of the patient ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy
Official Title  ICMJE Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hyperthyroid
Intervention  ICMJE Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 28, 2013)
252
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779817
Other Study ID Numbers  ICMJE PHRC 2011-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Angers
Study Sponsor  ICMJE University Hospital, Angers
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Natacha BOUHOURS-NOUET UNIVERSITY HOSPITAL OF ANGERS
PRS Account University Hospital, Angers
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP