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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Purpose
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MAIN OBJECTIVE :
To assess the consequences of a maternal hyperthyroïd during pregnancy on intellectual development of the child from 6 to 9 years
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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.
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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 |
- Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ]
- 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 |
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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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01779817
| Contact: Natacha BOUHOURS-NOUET | NaBouhours-Nouet@chu-angers.fr |
| 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 | |
| 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 |
Additional relevant MeSH terms:
|
Hyperthyroidism Endocrine System Diseases Thyroid Diseases |
ClinicalTrials.gov processed this record on February 27, 2015