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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03269110




Registration number
NCT03269110
Ethics application status
Date submitted
10/08/2017
Date registered
31/08/2017
Date last updated
14/05/2019

Titles & IDs
Public title
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Scientific title
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
Secondary ID [1] 0 0
CTO 816
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Asthma 0 0
Executive Dysfunction 0 0
Emotional Problem 0 0
Behavioural Problem 0 0
Pre-Eclampsia 0 0
Death 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 0 0 0 0
Hypertension
Mental Health 0 0 0 0
Autistic spectrum disorders
Mental Health 0 0 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - SRS 2, CBCL, BRIEF-P

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.


Diagnosis / Prognosis: SRS 2, CBCL, BRIEF-P
This study does not involve an intervention.

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.

Eligibility
Key inclusion criteria
1. Capability of participant to comprehend and comply with study requirements

2. Mother participated in FACT
Minimum age
4 Years
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Nepean - Penrith
Recruitment hospital [2] 0 0
Townsville - Douglas
Recruitment hospital [3] 0 0
Ipswich - Ipswich
Recruitment hospital [4] 0 0
Royal Women's - Parkville
Recruitment hospital [5] 0 0
Sunshine - St Albans
Recruitment hospital [6] 0 0
Women's and Children's Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2750 - Penrith
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
4305 - Ipswich
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Newfoundland and Labrador
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Canada
State/province [7] 0 0
Saskatchewan
Country [8] 0 0
Canada
State/province [8] 0 0
Montreal
Country [9] 0 0
Jamaica
State/province [9] 0 0
Kingston 7
Country [10] 0 0
Jamaica
State/province [10] 0 0
Kingston
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Cambridgeshire
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Cheshire
Country [13] 0 0
United Kingdom
State/province [13] 0 0
County Durham
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Lancashire
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Lincolnshire
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Middlesex
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Northumberland
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Tooting
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Tyne And Wear
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Blackburn
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Burnley
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Carlisle
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Crumpsall
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Durham
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Middlesbrough
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Newcastle upon Tyne
Country [28] 0 0
United Kingdom
State/province [28] 0 0
North Shields
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Norwich
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Nottingham
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Oldham
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Stockton
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Sunderland
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Uxbridge
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Warrington
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Whitehaven
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Whitley Bay
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Other
Name
Ottawa Hospital Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03269110
Trial related presentations / publications
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Public notes

Contacts
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Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03269110