<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03269110</url>
  </required_header>
  <id_info>
    <org_study_id>CTO 816</org_study_id>
    <nct_id>NCT03269110</nct_id>
  </id_info>
  <brief_title>Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)</brief_title>
  <official_title>Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical&#xD;
      Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high&#xD;
      dose folic acid supplementation on social impairments associated with Autism Spectrum&#xD;
      Disorders (ASDs), and deficiencies in a range of executive function and emotional and&#xD;
      behavioural problems in young children, and the risk of death.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Folic Acid Clinical Trial (FACT) was developed to conclusively determine the effect of&#xD;
      high dose folic acid supplementation in pregnancy on the prevention of preeclampsia in a&#xD;
      randomized controlled trial (RCT) design.&#xD;
&#xD;
      The primary objective of the FACT 4 Child study is to examine the effect of maternal folic&#xD;
      acid supplementation in pregnancy on the risk of social impairments, as well as executive&#xD;
      function, emotional and behavioural problems associated with Autism Spectrum Disorders (ASD)&#xD;
      and other developmental disorders, and death in offspring aged 4-6 y of mothers recruited to&#xD;
      the CIHR funded FACT.&#xD;
&#xD;
      The effect of folic acid supplementation throughout pregnancy may potentially have an impact&#xD;
      on both the mother and her offspring, which highlights the importance and relevance of this&#xD;
      study to the management of women with preeclampsia. Results of this study will allow care&#xD;
      providers to have the evidence of potential effects of high dose folic acid that can then be&#xD;
      discussed; allowing women to make an informed choice about their management and care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neurocognitive disability</measure>
    <time_frame>From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.</time_frame>
    <description>The primary outcome is a competing composite endpoint of neurocognitive disability and death. Neurocognitive disability is a composite outcome related to social impairments, executive function, emotional and behavioural problems which have been associated with Autism Spectrum Disorder (ASD). It will be defined by an abnormal score on any of three standardized and validated assessment tools: SRS-2 BRIEF-P, or CBCL which will be administered to the parents of children aged 4-6 years. Deaths reported between 6 weeks to 4-6 years of age will be recorded as a competing event and treated as part of the primary endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severe Morbidity</measure>
    <time_frame>From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.</time_frame>
    <description>Secondary outcomes to be assessed in FACT 4 Child include severe morbidity of FACT offspring, captured by the Mother-Child Health Survey at the age of 4 - 6 years, including incidence of: Severe morbidity defined by any illnesses during the previous years that has necessitated hospitalization or medication/treatment for &gt;2 months</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2578</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Asthma</condition>
  <condition>Executive Dysfunction</condition>
  <condition>Emotional Problem</condition>
  <condition>Behavioural Problem</condition>
  <condition>Pre-Eclampsia</condition>
  <condition>Death</condition>
  <arm_group>
    <arm_group_label>Mother and child(ren)</arm_group_label>
    <description>FACT 4 Child is the post-delivery follow-up of the offspring born to FACT mothers once these children are between the age of 4 - 6 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SRS 2, CBCL, BRIEF-P</intervention_name>
    <description>This study does not involve an intervention.</description>
    <arm_group_label>Mother and child(ren)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        FACT 4 Child is the post-delivery follow-up of offspring born to FACT mothers once children&#xD;
        reach the age of 4 years. Women in FACT and their children, will be invited to participate&#xD;
        in FACT 4 Child.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Capability of participant to comprehend and comply with study requirements&#xD;
&#xD;
          2. Mother participated in FACT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Confirmed spontaneous termination (miscarriage) or elective termination or stillborn&#xD;
&#xD;
          2. Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Walker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nepean</name>
      <address>
        <city>Penrith</city>
        <state>New South Wales</state>
        <zip>2750</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Townsville</name>
      <address>
        <city>Douglas</city>
        <state>Queensland</state>
        <zip>4814</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ipswich</name>
      <address>
        <city>Ipswich</city>
        <state>Queensland</state>
        <zip>4305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's and Children's Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Women's</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine</name>
      <address>
        <city>St Albans</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calgary Foothills Medical Center</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edmonton Lois Hole Hospital for Women</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winnipeg University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fredericton Dr. Everett Chalmers Regional Hospital</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 5N5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moncton Hospital</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1C 6Z8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-John's Women's Health Centre</name>
      <address>
        <city>St John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1B 3V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital, General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital, Civic Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quebec City (CHUL) Centre Hospitalier Universitaire</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sainte-Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Mary's Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Luc</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regina Qu'Appelle Health Region</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4P 0W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of West Indies</name>
      <address>
        <city>Kingston 7</city>
        <country>Jamaica</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jubilee</name>
      <address>
        <city>Kingston</city>
        <country>Jamaica</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spanishtown</name>
      <address>
        <city>Kingston</city>
        <country>Jamaica</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hinchingbrooke</name>
      <address>
        <city>Huntingdon</city>
        <state>Cambridgeshire</state>
        <zip>PE29 6NT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leighton</name>
      <address>
        <city>Crewe</city>
        <state>Cheshire</state>
        <zip>CW1 4QJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Darlington Memorial Hospital</name>
      <address>
        <city>Darlington</city>
        <state>County Durham</state>
        <zip>DL3 6HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairfield</name>
      <address>
        <city>Bury</city>
        <state>Lancashire</state>
        <zip>BL9 7TD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochdale</name>
      <address>
        <city>Rochdale</city>
        <state>Lancashire</state>
        <zip>OL12 0NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lincolnshire</name>
      <address>
        <city>Lincoln</city>
        <state>Lincolnshire</state>
        <zip>LN2 4AX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Middlesex University Hospital</name>
      <address>
        <city>Isleworth</city>
        <state>Middlesex</state>
        <zip>TW7 6AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wansbeck General Hospital</name>
      <address>
        <city>Ashington</city>
        <state>Northumberland</state>
        <zip>NE63 9JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>London</city>
        <state>Tooting</state>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gateshead Queen Elizabeth Hospital</name>
      <address>
        <city>Gateshead</city>
        <state>Tyne And Wear</state>
        <zip>NE9 6SX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Tyneside Distrcit Hospital</name>
      <address>
        <city>South Shields</city>
        <state>Tyne And Wear</state>
        <zip>NE34 0PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blackburn</name>
      <address>
        <city>Blackburn</city>
        <zip>BB2 3HH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burnley</name>
      <address>
        <city>Burnley</city>
        <zip>BB10 2PQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cumberland Infirmary Carlisle</name>
      <address>
        <city>Carlisle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Manchester</name>
      <address>
        <city>Crumpsall</city>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Durham</name>
      <address>
        <city>Durham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St. Thomas</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Tees Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle upon Tyne Hospitals</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Tyneside General Hospital</name>
      <address>
        <city>North Shields</city>
        <zip>NE29 8NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk &amp; Norwich</name>
      <address>
        <city>Norwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham City Hospital</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham Queens Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oldham</name>
      <address>
        <city>Oldham</city>
        <zip>OL1 2JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Tees Hospital</name>
      <address>
        <city>Stockton</city>
        <zip>TS19 9AH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunderland Royal Hospital</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillingdon Hospital</name>
      <address>
        <city>Uxbridge</city>
        <zip>UB8 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Warrington Hospital</name>
      <address>
        <city>Warrington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Cumberland Hospital</name>
      <address>
        <city>Whitehaven</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>49 Marine Avenue</name>
      <address>
        <city>Whitley Bay</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Wolverhampton - New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Jamaica</country>
    <country>United Kingdom</country>
  </location_countries>
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  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>September 18, 2022</last_update_submitted>
  <last_update_submitted_qc>September 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neurological</keyword>
  <keyword>autism</keyword>
  <keyword>ASD</keyword>
  <keyword>behaviour</keyword>
  <keyword>folic acid</keyword>
  <keyword>pre-eclampsia</keyword>
  <keyword>asthma</keyword>
  <keyword>executive function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03269110
org study id: CTO 816
nct id: NCT03269110
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical
      Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high
      dose folic acid supplementation on social impairments associated with Autism Spectrum
      Disorders (ASDs), and deficiencies in a range of executive function and emotional and
      behavioural problems in young children, and the risk of death.
The Folic Acid Clinical Trial (FACT) was developed to conclusively determine the effect of
      high dose folic acid supplementation in pregnancy on the prevention of preeclampsia in a
      randomized controlled trial (RCT) design.

      The primary objective of the FACT 4 Child study is to examine the effect of maternal folic
      acid supplementation in pregnancy on the risk of social impairments, as well as executive
      function, emotional and behavioural problems associated with Autism Spectrum Disorders (ASD)
      and other developmental disorders, and death in offspring aged 4-6 y of mothers recruited to
      the CIHR funded FACT.

      The effect of folic acid supplementation throughout pregnancy may potentially have an impact
      on both the mother and her offspring, which highlights the importance and relevance of this
      study to the management of women with preeclampsia. Results of this study will allow care
      providers to have the evidence of potential effects of high dose folic acid that can then be
      discussed; allowing women to make an informed choice about their management and care.
observational model: Cohort
time perspective: Prospective
measure: Neurocognitive disability
time frame: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
description: The primary outcome is a competing composite endpoint of neurocognitive disability and death. Neurocognitive disability is a composite outcome related to social impairments, executive function, emotional and behavioural problems which have been associated with Autism Spectrum Disorder (ASD). It will be defined by an abnormal score on any of three standardized and validated assessment tools: SRS-2 BRIEF-P, or CBCL which will be administered to the parents of children aged 4-6 years. Deaths reported between 6 weeks to 4-6 years of age will be recorded as a competing event and treated as part of the primary endpoint.
measure: Severe Morbidity
time frame: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
description: Secondary outcomes to be assessed in FACT 4 Child include severe morbidity of FACT offspring, captured by the Mother-Child Health Survey at the age of 4 - 6 years, including incidence of: Severe morbidity defined by any illnesses during the previous years that has necessitated hospitalization or medication/treatment for >2 months
arm group label: Mother and child(ren)
description: FACT 4 Child is the post-delivery follow-up of the offspring born to FACT mothers once these children are between the age of 4 - 6 years.
intervention type: Diagnostic Test
intervention name: SRS 2, CBCL, BRIEF-P
description: This study does not involve an intervention.
arm group label: Mother and child(ren)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Walker, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
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country: Australia
country: Canada
country: Jamaica
country: United Kingdom
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responsible party type: Sponsor
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: Autism Spectrum Disorder
mesh term: Problem Behavior
sharing ipd: No