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.
Study Type
OBSERVATIONAL
Enrollment
664
This study does not involve an intervention.
Nepean
Penrith, New South Wales, Australia
Townsville
Douglas, Queensland, Australia
Ipswich
Ipswich, Queensland, Australia
Women's and Children's Hospital
Adelaide, South Australia, Australia
Royal Women's
Parkville, Victoria, Australia
Sunshine
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.
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.
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
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.
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St Albans, Victoria, Australia
Calgary Foothills Medical Center
Calgary, Alberta, Canada
Edmonton Lois Hole Hospital for Women
Edmonton, Alberta, Canada
St-Paul's Hospital
Vancouver, British Columbia, Canada
Winnipeg University of Manitoba
Winnipeg, Manitoba, Canada
...and 48 more locations