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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Death; Asthma; Autism Spectrum Disorder; Pre-Eclampsia; Executive Dysfunction; Emotional Problem; Behavioural Problem
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Estimated): 2578

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Penrith, New South Wales, Australia, 2750
      • Nepean
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Townsville
    • Ipswich, Queensland, Australia, 4305
      • Ipswich
  • South Australia
    • Adelaide, South Australia, Australia
      • Women's and Children's Hospital
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Women's
    • St Albans, Victoria, Australia, 3021
      • Sunshine
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Calgary Foothills Medical Center
    • Edmonton, Alberta, Canada, T5H 3V9
      • Edmonton Lois Hole Hospital for Women
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • St-Paul's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Winnipeg University of Manitoba
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5N5
      • Fredericton Dr. Everett Chalmers Regional Hospital
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Moncton Hospital
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada, A1B 3V6
      • St-John's Women's Health Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Hamilton McMaster University
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston
    • London, Ontario, Canada, N6A 5W9
      • London
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital, Civic Campus
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital, General Campus
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences
  • Quebec
    • Montreal, Quebec, Canada, G1V 4G2
      • Quebec City (CHUL) Centre Hospitalier Universitaire
    • Montreal, Quebec, Canada, H3T 1C5
      • Sainte-Justine
    • Montreal, Quebec, Canada, H3T 1M5
      • St-Mary's Hospital
    • Montreal, Quebec, Canada
      • St-Luc
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Regina Qu'Appelle Health Region
• Jamaica
  • Kingston, Jamaica
    • Jubilee
  • Kingston, Jamaica
    • Spanishtown
  • Kingston 7, Jamaica
    • University of West Indies
• United Kingdom
  • Blackburn, United Kingdom, BB2 3HH
    • Blackburn
  • Burnley, United Kingdom, BB10 2PQ
    • Burnley
  • Carlisle, United Kingdom
    • Cumberland Infirmary Carlisle
  • Crumpsall, United Kingdom, M8 5RB
    • North Manchester
  • Durham, United Kingdom
    • North Durham
  • London, United Kingdom
    • Guy's and St. Thomas
  • Middlesbrough, United Kingdom, TS4 3BW
    • South Tees Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Newcastle upon Tyne Hospitals
  • North Shields, United Kingdom, NE29 8NH
    • North Tyneside General Hospital
  • Norwich, United Kingdom
    • Norfolk & Norwich
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham Queens Medical Centre
  • Oldham, United Kingdom, OL1 2JH
    • Oldham
  • Stockton, United Kingdom, TS19 9AH
    • North Tees Hospital
  • Sunderland, United Kingdom, SR4 7TP
    • Sunderland Royal Hospital
  • Uxbridge, United Kingdom, UB8 3NN
    • Hillingdon Hospital
  • Warrington, United Kingdom
    • Warrington Hospital
  • Whitehaven, United Kingdom
    • West Cumberland Hospital
  • Whitley Bay, United Kingdom
    • 49 Marine Avenue
  • Wolverhampton, United Kingdom
    • Royal Wolverhampton - New Cross Hospital
  • Cambridgeshire
    • Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
      • Hinchingbrooke
  • Cheshire
    • Crewe, Cheshire, United Kingdom, CW1 4QJ
      • Leighton
  • County Durham
    • Darlington, County Durham, United Kingdom, DL3 6HX
      • Darlington Memorial Hospital
  • Lancashire
    • Bury, Lancashire, United Kingdom, BL9 7TD
      • Fairfield
    • Rochdale, Lancashire, United Kingdom, OL12 0NB
      • Rochdale
  • Lincolnshire
    • Lincoln, Lincolnshire, United Kingdom, LN2 4AX
      • Lincolnshire
  • Middlesex
    • Isleworth, Middlesex, United Kingdom, TW7 6AF
      • West Middlesex University Hospital
  • Northumberland
    • Ashington, Northumberland, United Kingdom, NE63 9JJ
      • Wansbeck General Hospital
  • Tooting
    • London, Tooting, United Kingdom, SW17 0QT
      • St George's Hospital
  • Tyne And Wear
    • Gateshead, Tyne And Wear, United Kingdom, NE9 6SX
      • Gateshead Queen Elizabeth Hospital
    • South Shields, Tyne And Wear, United Kingdom, NE34 0PL
      • South Tyneside Distrcit Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive disability	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.	From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Morbidity	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	From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Mark Walker, MD, The Ottawa Hospital

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: asthma; autism; ASD; executive function; pre-eclampsia; neurological; folic acid; behaviour
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pregnancy Complications; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Problem Behavior; Autism Spectrum Disorder; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: CTO 816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No