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

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01779817
• Collaborator: (none)
• Enrollment: 252
• Locations: 13
• Arms: 2
• Duration (Months): 71
• Patients Per Site: 19.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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

1. SECONDARY OBJECTIVES :

2. 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.

3. 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 or Disease	Intervention/Treatment	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

Detailed Description

1. 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

1. 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

1. EXCLUSION CRITERIA :

o Discovered of a thyroid dysfonction at the time of the entry in the study

1. 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

• Study Type: Interventional
• Anticipated Enrollment: 252 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Assessment of Intellectual, Psychological and Behavioural Developments Between 6 and 9 Years of the Children Born to Hyperthyroid Mothers During Pregnancy
• Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.

Outcome Measures

Primary Outcome Measures

1. Scores of global development Quotient (WISC-R) [within the first 30 days after inclusion of the patient]

Secondary Outcome Measures

1. Score of the Achenbach Child Behavior Checklist [within the first 30 days after inclusion of the patient]

2. Score of the conners scale [within the first 30 days after inclusion of the patient]

3. Score of the Wechsler Intelligence Scale for Children (WISC-IV) [within the first 30 days after inclusion of the patient]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. 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 Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Amiens	Amiens		France
2	University Hospital of Angers	Angers		France	49000
3	Civil Hospices of Lyon	Bron		France	69677
4	University Hospital of Kremlin Bicetre	Le Kremlin Bicetre		France	94275
5	University Hospital of Lille	Lille		France
6	University Hospital of Marseille	Marseille		France
7	University Hospital of Nantes	Nantes		France	44093
8	Hospital of Saint Antoine	Paris		France	75012
9	University Hospital of Cochin	Paris		France	75014
10	University Hospital of Poitiers	Poitiers		France	86021
11	University Hospital of Reims	Reims		France	51092
12	University Hospital of Strasbourg	Strasbourg		France
13	University Hospital of Toulouse	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Angers

Investigators

• Principal Investigator: Natacha BOUHOURS-NOUET, UNIVERSITY HOSPITAL OF ANGERS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT01779817
• Other Study ID Numbers: PHRC 2011-01
• First Posted: Jan 30, 2013
• Last Update Posted: Jun 15, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Hyperthyroidism

Study Results

No Results Posted as of Jun 15, 2018