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

NCT03269110 | Completed DMC

• 1 other identifier: CTO 816
• Study Type: observational
• Target: 664
• Locations: 4 countries
• Sites: 58

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Severe Morbidity

  From six weeks of age to date of data collection taken at one time point between the ages of 4 to 6 years.

Study Arms (1)

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.

Diagnostic Test: SRS 2, CBCL, BRIEF-P

Interventions

SRS 2, CBCL, BRIEF-P DIAGNOSTIC_TEST

This study does not involve an intervention.

Mother and child(ren)

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Capability of participant to comprehend and comply with study requirements
• Mother participated in FACT

You may not qualify if:

• Confirmed spontaneous termination (miscarriage) or elective termination or stillborn
• Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (58)

Nepean

Penrith, New South Wales, 2750, Australia

Location

Townsville

Douglas, Queensland, 4814, Australia

Location

Ipswich

Ipswich, Queensland, 4305, Australia

Location

Women's and Children's Hospital

Adelaide, South Australia, Australia

Location

Royal Women's

Parkville, Victoria, 3052, Australia

Location

Sunshine

St Albans, Victoria, 3021, Australia

Location

Calgary Foothills Medical Center

Calgary, Alberta, T2N2T9, Canada

Location

Edmonton Lois Hole Hospital for Women

Edmonton, Alberta, T5H 3V9, Canada

Location

St-Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Winnipeg University of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Fredericton Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick, E3B 5N5, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

St-John's Women's Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Hamilton McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Kingston

Kingston, Ontario, K7L 2V7, Canada

Location

London

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences

Toronto, Ontario, M4N 3M5, Canada

Location

Quebec City (CHUL) Centre Hospitalier Universitaire

Montreal, Quebec, G1V 4G2, Canada

Location

Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

St-Mary's Hospital

Montreal, Quebec, H3T 1M5, Canada

Location

St-Luc

Montreal, Quebec, Canada

Location

Regina Qu'Appelle Health Region

Regina, Saskatchewan, S4P 0W5, Canada

Location

Jubilee

Kingston, Jamaica

Location

Spanishtown

Kingston, Jamaica

Location

University of West Indies

Kingston, Jamaica

Location

Hinchingbrooke

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

Location

Leighton

Crewe, Cheshire, CW1 4QJ, United Kingdom

Location

Darlington Memorial Hospital

Darlington, County Durham, DL3 6HX, United Kingdom

Location

Fairfield

Bury, Lancashire, BL9 7TD, United Kingdom

Location

Rochdale

Rochdale, Lancashire, OL12 0NB, United Kingdom

Location

Lincolnshire

Lincoln, Lincolnshire, LN2 4AX, United Kingdom

Location

West Middlesex University Hospital

Isleworth, Middlesex, TW7 6AF, United Kingdom

Location

Wansbeck General Hospital

Ashington, Northumberland, NE63 9JJ, United Kingdom

Location

St George's Hospital

London, Tooting, SW17 0QT, United Kingdom

Location

Gateshead Queen Elizabeth Hospital

Gateshead, Tyne and Wear, NE9 6SX, United Kingdom

Location

South Tyneside Distrcit Hospital

South Shields, Tyne and Wear, NE34 0PL, United Kingdom

Location

Blackburn

Blackburn, BB2 3HH, United Kingdom

Location

Burnley

Burnley, BB10 2PQ, United Kingdom

Location

Cumberland Infirmary Carlisle

Carlisle, United Kingdom

Location

North Manchester

Crumpsall, M8 5RB, United Kingdom

Location

North Durham

Durham, United Kingdom

Location

Guy's and St. Thomas

London, United Kingdom

Location

South Tees Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Newcastle upon Tyne Hospitals

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

North Tyneside General Hospital

North Shields, NE29 8NH, United Kingdom

Location

Norfolk & Norwich

Norwich, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Nottingham Queens Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

Oldham

Oldham, OL1 2JH, United Kingdom

Location

North Tees Hospital

Stockton, TS19 9AH, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, SR4 7TP, United Kingdom

Location

Hillingdon Hospital

Uxbridge, UB8 3NN, United Kingdom

Location

Warrington Hospital

Warrington, United Kingdom

Location

West Cumberland Hospital

Whitehaven, United Kingdom

Location

49 Marine Avenue

Whitley Bay, United Kingdom

Location

Royal Wolverhampton - New Cross Hospital

Wolverhampton, United Kingdom

Location

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  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Asthma; Mental Disorders; Pre-Eclampsia; Death; Neurologic Manifestations; Autistic Disorder; Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Signs and Symptoms

Study Officials

• Mark Walker, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 31, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); CA (18); GB (31); JA (3)