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Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)

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ClinicalTrials.gov Identifier: NCT03269110
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Asthma Executive Dysfunction Emotional Problem Behavioural Problem Pre-Eclampsia Death Diagnostic Test: SRS 2, CBCL, BRIEF-P

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 2578 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022


Group/Cohort Intervention/treatment
Mother and child(ren)
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.
Diagnostic Test: SRS 2, CBCL, BRIEF-P
This study does not involve an intervention.




Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. 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. ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
FACT 4 Child is the post-delivery follow-up of offspring born to FACT mothers once children reach the age of 4 years. Women in FACT and their children, will be invited to participate in FACT 4 Child.
Criteria

Inclusion Criteria:

  1. Capability of participant to comprehend and comply with study requirements
  2. Mother participated in FACT

Exclusion Criteria:

  1. Confirmed spontaneous termination (miscarriage) or elective termination or stillborn
  2. Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269110


  Show 59 Study Locations
Sponsors and Collaborators
Ottawa Hospital Research Institute

Publications:
Repchinsky C. CPS 2008: Compendium of Pharmaceuticals and Specialties : The Canadian Drug Reference for Health Professionals. United States: Canadian Pharmacists Association, 2008.
Gioia GA. Isquith PK GP, Kenworthy L. Behavior Rating Inventory of Executive Function (BRIEF). Odessa, Fl: Psychological Assessment Resources, 2000.
Achenbach TM, Dumenci, L., & Rescorla, L. A. Ten-Year Comparisons of Problems and Competencies for National Samples of Youth: Self, Parent, and Teacher Reports. Journal of Emotional and Behavioral Disorders 2002;10:194-203.
Constantino JN, & Gruber, C. P. Social Responsiveness Scale (SRS): Manual. Los Angeles: Western Psychological Services, 2005.
Wilkinson LA. A best practice guide to assessment and intervention for autism and Asperger syndrome in schools. London: Jessica Kingsley Publishers, 2010.
Constantino JNGC. Social Responsiveness Scale, Second Edition. Los Angeles: Western Psychological Services, 2012.
Gioia GA EK, & Isquith, PK. . Behavior Rating Inventory of Executive Function, Preschool Version. Lutz, Fl: Psychological Assessment Resources, Inc., 2003.
Achenbach TM, & Rescorla, L.A. Manual for the ASEBA Preschool forms and Profiles. Burlington, VT: University of Vermont Department of Psychiatry, 2000.
Achenbach T. Manual for the Child Behavior Checklist/2-1 and 1992 Profile. Burlington (VT): University of Vermont Department of Psychiatry, 1992.
Achenbach TM, & Rescorla, L. A. Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families, 2001.
AP Association. Diagnostic and statistical manual of mental disorders (5th Ed.). Washington, DC.: American Psychiatric Publishing, 2013.
Andrews, D. Children With School Problems: A Physician's Manual: The Canadian Paediatric Society, 2012.

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03269110     History of Changes
Other Study ID Numbers: CTO 816
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:
neurological
autism
ASD
behaviour
folic acid
pre-eclampsia
asthma
executive function

Additional relevant MeSH terms:
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Child Development Disorders, Pervasive
Autism Spectrum Disorder
Eclampsia
Pre-Eclampsia
Problem Behavior
Neurodevelopmental Disorders
Mental Disorders
Hypertension, Pregnancy-Induced
Pregnancy Complications
Behavioral Symptoms
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs