Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03269110|
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2017
Last Update Posted : August 6, 2020
|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|
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|
|Estimated Enrollment :||2578 participants|
|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|
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.
- 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.
- 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
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
|Principal Investigator:||Mark Walker, MD||The Ottawa Hospital|