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 not yet open for participant recruitment.
Verified January 2013 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01779817
First received: January 28, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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

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.

  Show Detailed Description

  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
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 Not yet 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 Not yet recruiting
Bron, France, 69677
Contact: Claire BOURNAUD       claire.bournaud@chu-lyon.fr   
Principal Investigator: Claire BOURNAUD         
Principal Investigator: Marc NICOLINO         
University Hospital of Kremlin Bicetre Not yet 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 Nantes Not yet recruiting
Nantes, France, 44093
Contact: Delphine DRUI       delphine.drui@chu-nantes.fr   
Principal Investigator: Delphine DRUI         
Hospital of Saint Antoine Not yet recruiting
Paris, France, 75012
Contact: Sophie CHRISTIN-MAITRE       sophie.christin-maitre@sat.aphp.fr   
Principal Investigator: Sophie CHRISTIN-MAITRE         
University Hospital of Cochin Not yet recruiting
Paris, France, 75014
Contact: Jérôme BERTHERAT       jerome.bertherat@cch.aphp.fr   
Principal Investigator: Jérôme BERTHERAT         
Sub-Investigator: Lionel GROUSSIN         
University Hospital of Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: Samy HADJADJ       s.hadjadj@chu-poitiers.fr   
Principal Investigator: Samy HADJADJ         
Sub-Investigator: Xavier PIGUEL         
University Hospital of Reims Not yet recruiting
Reims, France, 51092
Contact: Brigitte DELEMER       bdelemer@chu-reims.fr   
Principal Investigator: Brigitte DELEMER         
University Hospital of Strasbourg Not yet recruiting
Strasbourg, France
Contact: Nathalie JEANDIDIER       nathalie.jeandidier@chru-strasbourg.fr   
Principal Investigator: Nathalie JEANDIDIER         
Principal Investigator: SOSKIN Sylvie         
Principal Investigator: Bernard GOICHOT         
University Hospital of Toulouse Not yet recruiting
Toulouse, France, 31059
Contact: Maïthé TAUBER       tauber.mt@chu-toulouse.fr   
Principal Investigator: Maïthé TAUBER         
Sub-Investigator: Isabelle OLIVER-PETIT         
Principal Investigator: Philippe CARON         
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: January 28, 2013
Health Authority: France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on April 17, 2014