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

June 14, 2018 updated by: University Hospital, Angers

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

  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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

252

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • University Hospital of Amiens
        • Contact:
        • Principal Investigator:
          • RACHEL DESAILLOUD
        • Sub-Investigator:
          • HELENE Bony-Trifunovic
        • Sub-Investigator:
          • KARINE Braun
      • Angers, France, 49000
        • Recruiting
        • University hospital of Angers
        • Contact:
        • Principal Investigator:
          • Frédéric ILLOUZ
        • Sub-Investigator:
          • Régis COUTANT
        • Sub-Investigator:
          • Patrice RODIEN
        • Principal Investigator:
          • Natacha BOUHOURS-NOUET
      • Bron, France, 69677
        • Recruiting
        • Civil Hospices of Lyon
        • Contact:
        • Principal Investigator:
          • Claire BOURNAUD
        • Principal Investigator:
          • Marc Nicolino
        • Sub-Investigator:
          • Françoise BORSON-CHAZOT
      • Le Kremlin Bicetre, France, 94275
        • Recruiting
        • University Hospital of Kremlin Bicetre
        • Contact:
        • Principal Investigator:
          • Claire BOUVATTIER
        • Principal Investigator:
          • Philippe CHANSON
      • Lille, France
        • Active, not recruiting
        • University Hospital of Lille
      • Marseille, France
        • Active, not recruiting
        • University Hospital of Marseille
      • Nantes, France, 44093
        • Recruiting
        • University Hospital of Nantes
        • Contact:
        • Principal Investigator:
          • Delphine Drui
      • Paris, France, 75012
      • Paris, France, 75014
        • Active, not recruiting
        • University Hospital of Cochin
      • Poitiers, France, 86021
        • Recruiting
        • University hospital of Poitiers
        • Contact:
        • Principal Investigator:
          • Samy HADJADJ
        • Sub-Investigator:
          • Xavier PIGUEL
      • Reims, France, 51092
        • Active, not recruiting
        • University Hospital of Reims
      • Strasbourg, France
        • Active, not recruiting
        • University Hospital of Strasbourg
      • Toulouse, France, 31059
        • Active, not recruiting
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scores of global development Quotient (WISC-R)
Time Frame: within the first 30 days after inclusion of the patient
within the first 30 days after inclusion of the patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Score of the Achenbach Child Behavior Checklist
Time Frame: within the first 30 days after inclusion of the patient
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
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
within the first 30 days after inclusion of the patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Natacha BOUHOURS-NOUET, University hospital of Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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