HyperthyroidPhase 4EDIEMHYPERNCT01779817
Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy
A Phase 4 study testing Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. in people with Hyperthyroid, run by University Hospital, Angers at 13 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthyroid
- What is being tested?
- Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 13 sitesFrance
- Study dates
- Feb 2013to Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
- 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
Trial locations and contacts
13 sites in 1 country.
Natacha BOUHOURS-NOUET contact
13 sites in 1 country
France13 sites, 7 recruiting
- Recruiting
University Hospital of Amiens
Amiens
RACHEL DESAILLOUD, Desailloud.Rachel@chu-amiens.fr
RACHEL DESAILLOUD
- Recruiting
University Hospital of Angers
Angers, 49000
Natacha BOUHOURS-NOUET, NaBouhours-Nouet@chu-angers.fr
Frédéric ILLOUZ
- Recruiting
Civil Hospices of Lyon
Bron, 69677
Claire BOURNAUD, claire.bournaud@chu-lyon.fr
Claire BOURNAUD
- Recruiting
University Hospital of Kremlin Bicetre
Le Kremlin-Bicêtre, 94275
Claire BOUVATTIER, claire.bouvattier@bct.aphp.fr
Claire BOUVATTIER
- Active, not recruiting
University Hospital of Lille
Lille
- Active, not recruiting
University Hospital of Marseille
Marseille
- Recruiting
University Hospital of Nantes
Nantes, 44093
Delphine DRUI, delphine.drui@chu-nantes.fr
Delphine DRUI
- Recruiting
Hospital of Saint Antoine
Paris, 75012
Sophie CHRISTIN-MAITRE, sophie.christin-maitre@sat.aphp.fr
Sophie CHRISTIN-MAITRE
- Active, not recruiting
University Hospital of Cochin
Paris, 75014
- Recruiting
University Hospital of Poitiers
Poitiers, 86021
Samy HADJADJ, s.hadjadj@chu-poitiers.fr
Samy HADJADJ
- Active, not recruiting
University Hospital of Reims
Reims, 51092
- Active, not recruiting
University Hospital of Strasbourg
Strasbourg
- Active, not recruiting
University Hospital of Toulouse
Toulouse, 31059
About this study
Official title: Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy
- 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).
Read the 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 :
- 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).
- Conditions
- Hyperthyroid
- Being tested
- Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.Behavioural
| Study group | Role | What they receive |
|---|---|---|
| child born to hyperthyroid mother during pregnancy | Other | Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. Receives: 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 | Other | Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. Receives: Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of global development Quotient (WISC-R)
Measured: within the first 30 days after inclusion of the patient
Secondary outcomes (3)
Score of the Achenbach Child Behavior Checklist
Measured: within the first 30 days after inclusion of the patient
Score of the conners scale
Measured: within the first 30 days after inclusion of the patient
Score of the Wechsler Intelligence Scale for Children (WISC-IV)
Measured: within the first 30 days after inclusion of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthyroidStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Natacha BOUHOURS-NOUET, Principal investigator, UNIVERSITY HOSPITAL OF ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779817
- Sponsor's protocol ID
- PHRC 2011-01
- Acronym
- EDIEMHYPER
- Status last verified
- Jun 2018
- First submitted
- 28 Jan 2013
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy
- ClinicalTrials.gov ID
- NCT01779817
- Acronym / sponsor ID
- EDIEMHYPER / PHRC 2011-01
- Conditions
- Hyperthyroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2013
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 :
- 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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| child born to hyperthyroid mother during pregnancy | Other | Behavioral: 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. |
| child born to euthyroid mother during pregnancy | Other | Behavioral: 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. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. | Behavioural | child born to euthyroid mother during pregnancy, child born to hyperthyroid mother during pregnancy |
Primary outcome
Scores of global development Quotient (WISC-R)
Time frame: within the first 30 days after inclusion of the patient
3 secondary outcomes
Score of the Achenbach Child Behavior Checklist
Time frame: 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
Score of the Wechsler Intelligence Scale for Children (WISC-IV)
Time frame: within the first 30 days after inclusion of the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natacha BOUHOURS-NOUET contact
Natacha BOUHOURS-NOUET principal investigator
UNIVERSITY HOSPITAL OF ANGERS
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years. in people with Hyperthyroid, run by University Hospital, Angers at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha BOUHOURS-NOUET (NaBouhours-Nouet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of global development Quotient (WISC-R) (time frame: within the first 30 days after inclusion of the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.