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

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03269110
• Collaborator: (none)
• Enrollment: 2,578
• Locations: 58
• Anticipated Duration (Months): 60
• Patients Per Site: 44.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder; Asthma; Executive Dysfunction; Emotional Problem; Behavioural Problem; Pre-Eclampsia; Death	Diagnostic Test: SRS 2, CBCL, BRIEF-P

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2578 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)
• Actual Study Start Date: Jul 1, 2017
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; This study does not involve an intervention.

Outcome Measures

Primary Outcome Measures

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

   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.

Secondary Outcome Measures

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.]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nepean	Penrith	New South Wales	Australia	2750
2	Townsville	Douglas	Queensland	Australia	4814
3	Ipswich	Ipswich	Queensland	Australia	4305
4	Women's and Children's Hospital	Adelaide	South Australia	Australia
5	Royal Women's	Parkville	Victoria	Australia	3052
6	Sunshine	St Albans	Victoria	Australia	3021
7	Calgary Foothills Medical Center	Calgary	Alberta	Canada	T2N2T9
8	Edmonton Lois Hole Hospital for Women	Edmonton	Alberta	Canada	T5H 3V9
9	St-Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 2K5
10	Winnipeg University of Manitoba	Winnipeg	Manitoba	Canada	R3E 3P4
11	Fredericton Dr. Everett Chalmers Regional Hospital	Fredericton	New Brunswick	Canada	E3B 5N5
12	Moncton Hospital	Moncton	New Brunswick	Canada	E1C 6Z8
13	St-John's Women's Health Centre	St John's	Newfoundland and Labrador	Canada	A1B 3V6
14	Hamilton McMaster University	Hamilton	Ontario	Canada	L8S 4K1
15	Kingston	Kingston	Ontario	Canada	K7L 2V7
16	London	London	Ontario	Canada	N6A 5W9
17	The Ottawa Hospital, General Campus	Ottawa	Ontario	Canada	K1H 8L6
18	The Ottawa Hospital, Civic Campus	Ottawa	Ontario	Canada	K1Y 4E9
19	Sunnybrook Health Sciences	Toronto	Ontario	Canada	M4N 3M5
20	Quebec City (CHUL) Centre Hospitalier Universitaire	Montreal	Quebec	Canada	G1V 4G2
21	Sainte-Justine	Montreal	Quebec	Canada	H3T 1C5
22	St-Mary's Hospital	Montreal	Quebec	Canada	H3T 1M5
23	St-Luc	Montreal	Quebec	Canada
24	Regina Qu'Appelle Health Region	Regina	Saskatchewan	Canada	S4P 0W5
25	University of West Indies	Kingston 7		Jamaica
26	Jubilee	Kingston		Jamaica
27	Spanishtown	Kingston		Jamaica
28	Hinchingbrooke	Huntingdon	Cambridgeshire	United Kingdom	PE29 6NT
29	Leighton	Crewe	Cheshire	United Kingdom	CW1 4QJ
30	Darlington Memorial Hospital	Darlington	County Durham	United Kingdom	DL3 6HX
31	Fairfield	Bury	Lancashire	United Kingdom	BL9 7TD
32	Rochdale	Rochdale	Lancashire	United Kingdom	OL12 0NB
33	Lincolnshire	Lincoln	Lincolnshire	United Kingdom	LN2 4AX
34	West Middlesex University Hospital	Isleworth	Middlesex	United Kingdom	TW7 6AF
35	Wansbeck General Hospital	Ashington	Northumberland	United Kingdom	NE63 9JJ
36	St George's Hospital	London	Tooting	United Kingdom	SW17 0QT
37	Gateshead Queen Elizabeth Hospital	Gateshead	Tyne And Wear	United Kingdom	NE9 6SX
38	South Tyneside Distrcit Hospital	South Shields	Tyne And Wear	United Kingdom	NE34 0PL
39	Blackburn	Blackburn		United Kingdom	BB2 3HH
40	Burnley	Burnley		United Kingdom	BB10 2PQ
41	Cumberland Infirmary Carlisle	Carlisle		United Kingdom
42	North Manchester	Crumpsall		United Kingdom	M8 5RB
43	North Durham	Durham		United Kingdom
44	Guy's and St. Thomas	London		United Kingdom
45	South Tees Hospital	Middlesbrough		United Kingdom	TS4 3BW
46	Newcastle upon Tyne Hospitals	Newcastle upon Tyne		United Kingdom	NE1 4LP
47	North Tyneside General Hospital	North Shields		United Kingdom	NE29 8NH
48	Norfolk & Norwich	Norwich		United Kingdom
49	Nottingham City Hospital	Nottingham		United Kingdom	NG5 1PB
50	Nottingham Queens Medical Centre	Nottingham		United Kingdom	NG7 2UH
51	Oldham	Oldham		United Kingdom	OL1 2JH
52	North Tees Hospital	Stockton		United Kingdom	TS19 9AH
53	Sunderland Royal Hospital	Sunderland		United Kingdom	SR4 7TP
54	Hillingdon Hospital	Uxbridge		United Kingdom	UB8 3NN
55	Warrington Hospital	Warrington		United Kingdom
56	West Cumberland Hospital	Whitehaven		United Kingdom
57	49 Marine Avenue	Whitley Bay		United Kingdom
58	Royal Wolverhampton - New Cross Hospital	Wolverhampton		United Kingdom

Sponsors and Collaborators

• Ottawa Hospital Research Institute

Investigators

• Principal Investigator: Mark Walker, MD, The Ottawa Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03269110
• Other Study ID Numbers: CTO 816
• First Posted: Aug 31, 2017
• Last Update Posted: Aug 6, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ottawa Hospital Research Institute: neurological; autism; ASD; behaviour; folic acid; pre-eclampsia; asthma; executive function
• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia; Autism Spectrum Disorder; Problem Behavior

Study Results

No Results Posted as of Aug 6, 2020