Clinical trial NCT03269110: Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Official title: Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Asthma
Executive Dysfunction
Emotional Problem
Behavioural Problem
Pre-Eclampsia
Death
Keywords: neurological
autism
ASD
behaviour
folic acid
pre-eclampsia
asthma
executive function
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 664
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FACT 4 Child is the post-delivery follow-up of offspring born to FACT mothers once children reach the age of 4 years. Women in FACT and their children, will be invited to participate in FACT 4 Child.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurocognitive disability
timeFrame: 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:
measure: Severe Morbidity
timeFrame: From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
Other outcomes:
Locations:
city: Penrith
country: Australia
facility: Nepean
state: New South Wales
city: Douglas
country: Australia
facility: Townsville
state: Queensland
city: Ipswich
country: Australia
facility: Ipswich
state: Queensland
city: Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Women's
state: Victoria
city: St Albans
country: Australia
facility: Sunshine
state: Victoria
city: Calgary
country: Canada
facility: Calgary Foothills Medical Center
state: Alberta
city: Edmonton
country: Canada
facility: Edmonton Lois Hole Hospital for Women
state: Alberta
city: Vancouver
country: Canada
facility: St-Paul's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg University of Manitoba
state: Manitoba
city: Fredericton
country: Canada
facility: Fredericton Dr. Everett Chalmers Regional Hospital
state: New Brunswick
city: Moncton
country: Canada
facility: Moncton Hospital
state: New Brunswick
city: St John's
country: Canada
facility: St-John's Women's Health Centre
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Hamilton McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Kingston
state: Ontario
city: London
country: Canada
facility: London
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences
state: Ontario
city: Montreal
country: Canada
facility: Quebec City (CHUL) Centre Hospitalier Universitaire
state: Quebec
city: Montreal
country: Canada
facility: Sainte-Justine
state: Quebec
city: Montreal
country: Canada
facility: St-Mary's Hospital
state: Quebec
city: Montreal
country: Canada
facility: St-Luc
state: Quebec
city: Regina
country: Canada
facility: Regina Qu'Appelle Health Region
state: Saskatchewan
city: Kingston 7
country: Jamaica
facility: University of West Indies
city: Kingston
country: Jamaica
facility: Jubilee
city: Kingston
country: Jamaica
facility: Spanishtown
city: Huntingdon
country: United Kingdom
facility: Hinchingbrooke
state: Cambridgeshire
city: Crewe
country: United Kingdom
facility: Leighton
state: Cheshire
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
state: County Durham
city: Bury
country: United Kingdom
facility: Fairfield
state: Lancashire
city: Rochdale
country: United Kingdom
facility: Rochdale
state: Lancashire
city: Lincoln
country: United Kingdom
facility: Lincolnshire
state: Lincolnshire
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
state: Middlesex
city: Ashington
country: United Kingdom
facility: Wansbeck General Hospital
state: Northumberland
city: London
country: United Kingdom
facility: St George's Hospital
state: Tooting
city: Gateshead
country: United Kingdom
facility: Gateshead Queen Elizabeth Hospital
state: Tyne And Wear
city: South Shields
country: United Kingdom
facility: South Tyneside Distrcit Hospital
state: Tyne And Wear
city: Blackburn
country: United Kingdom
facility: Blackburn
city: Burnley
country: United Kingdom
facility: Burnley
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary Carlisle
city: Crumpsall
country: United Kingdom
facility: North Manchester
city: Durham
country: United Kingdom
facility: North Durham
city: London
country: United Kingdom
facility: Guy's and St. Thomas
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Queens Medical Centre
city: Oldham
country: United Kingdom
facility: Oldham
city: Stockton
country: United Kingdom
facility: North Tees Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Uxbridge
country: United Kingdom
facility: Hillingdon Hospital
city: Warrington
country: United Kingdom
facility: Warrington Hospital
city: Whitehaven
country: United Kingdom
facility: West Cumberland Hospital
city: Whitley Bay
country: United Kingdom
facility: 49 Marine Avenue
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton - New Cross Hospital
Study officials:
affiliation: The Ottawa Hospital
name: Mark Walker, MD
role: PRINCIPAL_INVESTIGATOR
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