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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03269110
Other study ID # CTO 816
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 1, 2017
Est. completion date July 31, 2024

Study information

Verified date March 2024
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Enrolling by invitation
Enrollment 2578
Est. completion date July 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
SRS 2, CBCL, BRIEF-P
This study does not involve an intervention.

Locations

Country Name City State
Australia Women's and Children's Hospital Adelaide South Australia
Australia Townsville Douglas Queensland
Australia Ipswich Ipswich Queensland
Australia Royal Women's Parkville Victoria
Australia Nepean Penrith New South Wales
Australia Sunshine St Albans Victoria
Canada Calgary Foothills Medical Center Calgary Alberta
Canada Edmonton Lois Hole Hospital for Women Edmonton Alberta
Canada Fredericton Dr. Everett Chalmers Regional Hospital Fredericton New Brunswick
Canada Hamilton McMaster University Hamilton Ontario
Canada Kingston Kingston Ontario
Canada London London Ontario
Canada Moncton Hospital Moncton New Brunswick
Canada Quebec City (CHUL) Centre Hospitalier Universitaire Montreal Quebec
Canada Sainte-Justine Montreal Quebec
Canada St-Luc Montreal Quebec
Canada St-Mary's Hospital Montreal Quebec
Canada The Ottawa Hospital, Civic Campus Ottawa Ontario
Canada The Ottawa Hospital, General Campus Ottawa Ontario
Canada Regina Qu'Appelle Health Region Regina Saskatchewan
Canada St-John's Women's Health Centre St John's Newfoundland and Labrador
Canada Sunnybrook Health Sciences Toronto Ontario
Canada St-Paul's Hospital Vancouver British Columbia
Canada Winnipeg University of Manitoba Winnipeg Manitoba
Jamaica Jubilee Kingston
Jamaica Spanishtown Kingston
Jamaica University of West Indies Kingston 7
United Kingdom Wansbeck General Hospital Ashington Northumberland
United Kingdom Blackburn Blackburn
United Kingdom Burnley Burnley
United Kingdom Fairfield Bury Lancashire
United Kingdom Cumberland Infirmary Carlisle Carlisle
United Kingdom Leighton Crewe Cheshire
United Kingdom North Manchester Crumpsall
United Kingdom Darlington Memorial Hospital Darlington County Durham
United Kingdom North Durham Durham
United Kingdom Gateshead Queen Elizabeth Hospital Gateshead Tyne And Wear
United Kingdom Hinchingbrooke Huntingdon Cambridgeshire
United Kingdom West Middlesex University Hospital Isleworth Middlesex
United Kingdom Lincolnshire Lincoln Lincolnshire
United Kingdom Guy's and St. Thomas London
United Kingdom St George's Hospital London Tooting
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 Oldham Oldham
United Kingdom Rochdale Rochdale Lancashire
United Kingdom South Tyneside Distrcit Hospital South Shields Tyne And Wear
United Kingdom North Tees Hospital Stockton
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

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Countries where clinical trial is conducted

Australia,  Canada,  Jamaica,  United Kingdom, 

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* Note: There are 75 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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