Assessment of Intellectual, Psychological and Behavioural... | NCT01779817

Studies
Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Their Pregnancy

NCT01779817

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Jun 15, 2018Actual

Enrollment

252Estimated

Phase

Phase 4

Conditions

Hyperthyroid

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jan 2019Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Jan 28, 2013

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2018

Last Update Posted Date

Jun 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 :
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).

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).

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.	Behavioral		child born to euthyroid mother during pregnancy child born to hyperthyroid mother during pregnancy

Measure	Description	Time Frame
Scores of global development Quotient (WISC-R)		within the first 30 days after inclusion of the patient

Measure	Description	Time Frame
Score of the Achenbach Child Behavior Checklist		within the first 30 days after inclusion of the patient
Score of the conners scale		within the first 30 days after inclusion of the patient

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases