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

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.

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Key information

Conditions

Autism Spectrum Disorder Asthma Autistic Disorder Behavior Behavioural Problem Bronchial Diseases Child Development Disorders, Pervasive Death Emotional Problem Executive Dysfunction Female Urogenital Diseases and Pregnancy Complications Hypersensitivity Hypersensitivity, Immediate Hypertension, Pregnancy-Induced Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms Urogenital Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nepean, Penrith, New South Wales, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SRS 2, CBCL, BRIEF-P

Diagnostic Test

This study does not involve an intervention.

Primary outcomes

Neurocognitive disability

Time frame: 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 outcomes

Severe Morbidity

Time frame: 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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Aug 31, 2017
Registry last updated: Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed