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

• ClinicalTrials.gov Identifier: NCT01779817
• Recruitment Status: Unknown
• First Posted: January 30, 2013
• Last Update Posted: June 15, 2018
• Sponsor: University Hospital, Angers
• Information provided by (Responsible Party): University Hospital, Angers

Tracking Information

• First Submitted Date: January 28, 2013
• First Posted Date: January 30, 2013
• Last Update Posted Date: June 15, 2018
• Study Start Date: February 2013
• Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 28, 2013): Scores of global development Quotient (WISC-R) [ Time Frame: within the first 30 days after inclusion of the patient ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 28, 2013)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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

2. 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

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

2. 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

3. EXCLUSION CRITERIA :

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

4. 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Hyperthyroid
• Intervention: Behavioral: Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 28, 2013): 252
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2019
• Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

2. 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 9 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01779817
• Other Study ID Numbers: PHRC 2011-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Angers
• Study Sponsor: University Hospital, Angers
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital, Angers
• Verification Date: June 2018