Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
- Conditions
- Pre-EclampsiaExecutive DysfunctionAutism Spectrum DisorderAsthmaEmotional ProblemBehavioural ProblemDeath
- Interventions
- Diagnostic Test: SRS 2, CBCL, BRIEF-P
- Registration Number
- NCT03269110
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 664
- Capability of participant to comprehend and comply with study requirements
- Mother participated in FACT
- Confirmed spontaneous termination (miscarriage) or elective termination or stillborn
- Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mother and child(ren) SRS 2, CBCL, BRIEF-P 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.
- Primary Outcome Measures
Name Time Method Neurocognitive disability 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
Name Time Method Severe Morbidity 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
Trial Locations
- Locations (58)
Spanishtown
🇯🇲Kingston, Jamaica
Leighton
🇬🇧Crewe, Cheshire, United Kingdom
North Manchester
🇬🇧Crumpsall, United Kingdom
Lincolnshire
🇬🇧Lincoln, Lincolnshire, United Kingdom
Oldham
🇬🇧Oldham, United Kingdom
Rochdale
🇬🇧Rochdale, Lancashire, United Kingdom
Darlington Memorial Hospital
🇬🇧Darlington, County Durham, United Kingdom
Hinchingbrooke
🇬🇧Huntingdon, Cambridgeshire, United Kingdom
Fairfield
🇬🇧Bury, Lancashire, United Kingdom
Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Nepean
🇦🇺Penrith, New South Wales, Australia
Townsville
🇦🇺Douglas, Queensland, Australia
Ipswich
🇦🇺Ipswich, Queensland, Australia
Royal Women's
🇦🇺Parkville, Victoria, Australia
Edmonton Lois Hole Hospital for Women
🇨🇦Edmonton, Alberta, Canada
Calgary Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
Sunshine
🇦🇺St Albans, Victoria, Australia
St-Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Fredericton Dr. Everett Chalmers Regional Hospital
🇨🇦Fredericton, New Brunswick, Canada
Hamilton McMaster University
🇨🇦Hamilton, Ontario, Canada
Winnipeg University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Kingston
🇨🇦Kingston, Ontario, Canada
St-Mary's Hospital
🇨🇦Montreal, Quebec, Canada
St-John's Women's Health Centre
🇨🇦St John's, Newfoundland and Labrador, Canada
The Ottawa Hospital, General Campus
🇨🇦Ottawa, Ontario, Canada
Sainte-Justine
🇨🇦Montreal, Quebec, Canada
The Ottawa Hospital, Civic Campus
🇨🇦Ottawa, Ontario, Canada
Quebec City (CHUL) Centre Hospitalier Universitaire
🇨🇦Montreal, Quebec, Canada
Sunnybrook Health Sciences
🇨🇦Toronto, Ontario, Canada
London
🇨🇦London, Ontario, Canada
St-Luc
🇨🇦Montreal, Quebec, Canada
Regina Qu'Appelle Health Region
🇨🇦Regina, Saskatchewan, Canada
University of West Indies
🇯🇲Kingston 7, Jamaica
Jubilee
🇯🇲Kingston, Jamaica
Wansbeck General Hospital
🇬🇧Ashington, Northumberland, United Kingdom
West Middlesex University Hospital
🇬🇧Isleworth, Middlesex, United Kingdom
St George's Hospital
🇬🇧London, Tooting, United Kingdom
Gateshead Queen Elizabeth Hospital
🇬🇧Gateshead, Tyne And Wear, United Kingdom
South Tyneside Distrcit Hospital
🇬🇧South Shields, Tyne And Wear, United Kingdom
Burnley
🇬🇧Burnley, United Kingdom
Cumberland Infirmary Carlisle
🇬🇧Carlisle, United Kingdom
Blackburn
🇬🇧Blackburn, United Kingdom
North Tees Hospital
🇬🇧Stockton, United Kingdom
Guy's and St. Thomas
🇬🇧London, United Kingdom
North Durham
🇬🇧Durham, United Kingdom
South Tees Hospital
🇬🇧Middlesbrough, United Kingdom
Newcastle upon Tyne Hospitals
🇬🇧Newcastle upon Tyne, United Kingdom
North Tyneside General Hospital
🇬🇧North Shields, United Kingdom
Norfolk & Norwich
🇬🇧Norwich, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Nottingham Queens Medical Centre
🇬🇧Nottingham, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Hillingdon Hospital
🇬🇧Uxbridge, United Kingdom
Warrington Hospital
🇬🇧Warrington, United Kingdom
West Cumberland Hospital
🇬🇧Whitehaven, United Kingdom
49 Marine Avenue
🇬🇧Whitley Bay, United Kingdom
Royal Wolverhampton - New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Women's and Children's Hospital
🇦🇺Adelaide, South Australia, Australia