Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03269110
Ethics application status
Date submitted
10/08/2017
Date registered
31/08/2017

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
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
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
Sex
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
1/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
2578
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,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
Women's and Children's Hospital - Adelaide
Recruitment hospital [5] 0 0
Royal Women's - Parkville
Recruitment hospital [6] 0 0
Sunshine - St Albans
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
- Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
3021 - St Albans
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
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Newfoundland and Labrador
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Walker, MD
Address 0 0
The Ottawa Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03269110