Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy (EDIEMHYPER)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 28, 2013 | ||||
| Last Updated Date | January 28, 2013 | ||||
| Start Date ICMJE | February 2013 | ||||
| Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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 |
|
||||
| Detailed Description |
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).
|
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
||||
| 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 Arm (s) |
|
||||
| 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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 252 | ||||
| Estimated Completion Date | February 2016 | ||||
| Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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 |
||||
| Gender | Both | ||||
| Ages | 6 Years to 9 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01779817 | ||||
| Other Study ID Numbers ICMJE | PHRC 2011-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital, Angers | ||||
| Study Sponsor ICMJE | University Hospital, Angers | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University Hospital, Angers | ||||
| Verification Date | January 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||