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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)

Primary Purpose

Hyperthyroid

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hyperthyroid

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

  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

Sites / Locations

  • University Hospital of AmiensRecruiting
  • University Hospital of AngersRecruiting
  • Civil Hospices of LyonRecruiting
  • University Hospital of Kremlin BicetreRecruiting
  • University Hospital of Lille
  • University Hospital of Marseille
  • University Hospital of NantesRecruiting
  • Hospital of Saint AntoineRecruiting
  • University Hospital of Cochin
  • University Hospital of PoitiersRecruiting
  • University Hospital of Reims
  • University Hospital of Strasbourg
  • University Hospital of Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

child born to hyperthyroid mother during pregnancy

child born to euthyroid mother during pregnancy

Arm Description

Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Outcomes

Primary Outcome Measures

Scores of global development Quotient (WISC-R)

Secondary Outcome Measures

Score of the Achenbach Child Behavior Checklist
Score of the conners scale
Score of the Wechsler Intelligence Scale for Children (WISC-IV)

Full Information

First Posted
January 28, 2013
Last Updated
June 14, 2018
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01779817
Brief Title
Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy
Acronym
EDIEMHYPER
Official Title
Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
MAIN OBJECTIVE : To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual development of the child from 6 to 9 years SECONDARY OBJECTIVES : 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. 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
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 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 EXCLUSION CRITERIA : o Discovered of a thyroid dysfonction at the time of the entry in the study 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroid

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
child born to hyperthyroid mother during pregnancy
Arm Type
Other
Arm Description
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Arm Title
child born to euthyroid mother during pregnancy
Arm Type
Other
Arm Description
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Intervention Type
Behavioral
Intervention Name(s)
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
Primary Outcome Measure Information:
Title
Scores of global development Quotient (WISC-R)
Time Frame
within the first 30 days after inclusion of the patient
Secondary Outcome Measure Information:
Title
Score of the Achenbach Child Behavior Checklist
Time Frame
within the first 30 days after inclusion of the patient
Title
Score of the conners scale
Time Frame
within the first 30 days after inclusion of the patient
Title
Score of the Wechsler Intelligence Scale for Children (WISC-IV)
Time Frame
within the first 30 days after inclusion of the patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natacha BOUHOURS-NOUET
Email
NaBouhours-Nouet@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natacha BOUHOURS-NOUET
Organizational Affiliation
UNIVERSITY HOSPITAL OF ANGERS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Amiens
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RACHEL DESAILLOUD
Email
Desailloud.Rachel@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
RACHEL DESAILLOUD
First Name & Middle Initial & Last Name & Degree
HELENE Bony-Trifunovic
First Name & Middle Initial & Last Name & Degree
KARINE Braun
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha BOUHOURS-NOUET
Email
NaBouhours-Nouet@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Frédéric ILLOUZ
First Name & Middle Initial & Last Name & Degree
Régis COUTANT
First Name & Middle Initial & Last Name & Degree
Patrice RODIEN
First Name & Middle Initial & Last Name & Degree
Natacha BOUHOURS-NOUET
Facility Name
Civil Hospices of Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BOURNAUD
Email
claire.bournaud@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Claire BOURNAUD
First Name & Middle Initial & Last Name & Degree
Marc NICOLINO
First Name & Middle Initial & Last Name & Degree
Françoise BORSON-CHAZOT
Facility Name
University Hospital of Kremlin Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BOUVATTIER
Email
claire.bouvattier@bct.aphp.fr
First Name & Middle Initial & Last Name & Degree
Claire BOUVATTIER
First Name & Middle Initial & Last Name & Degree
Philippe CHANSON
Facility Name
University Hospital of Lille
City
Lille
Country
France
Individual Site Status
Active, not recruiting
Facility Name
University Hospital of Marseille
City
Marseille
Country
France
Individual Site Status
Active, not recruiting
Facility Name
University Hospital of Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine DRUI
Email
delphine.drui@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Delphine DRUI
Facility Name
Hospital of Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie CHRISTIN-MAITRE
Email
sophie.christin-maitre@sat.aphp.fr
First Name & Middle Initial & Last Name & Degree
Sophie CHRISTIN-MAITRE
Facility Name
University Hospital of Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Active, not recruiting
Facility Name
University Hospital of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samy HADJADJ
Email
s.hadjadj@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Samy HADJADJ
First Name & Middle Initial & Last Name & Degree
Xavier PIGUEL
Facility Name
University Hospital of Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Active, not recruiting
Facility Name
University Hospital of Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Active, not recruiting
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

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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

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