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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03269110
• Other study ID #: CTO 816
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Autism Spectrum Disorder
• Behavioural Problem
• Death
• Eclampsia
• Emotional Problem
• Executive Dysfunction
• Pre-Eclampsia
• Problem Behavior

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 all — Click 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.