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Clinical Trials/NCT04443179
NCT04443179
Recruiting
Not Applicable

Brain Imaging and Infant Development

King's College London1 site in 1 country790 target enrollmentApril 5, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
King's College London
Enrollment
790
Locations
1
Primary Endpoint
Neurodevelopmental Outcomes
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aims of the BIBS Study

The Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby's brain develops from before birth, up until 3-4 years of age. Working with children from a variety of backgrounds and communities, the investigators use a combination of state-of-the-art diagnostic tools such as MRI scans alongside traditional behavioural assessments to capture the earliest information on infant brain development.

The focus of the BIBS study

MRI scanning is a safe way of producing detailed images using strong magnetic fields and radio waves. It does not use X-ray. Along with learning more about brain development in general, the investigators also try to identify features that may in future help predict whether a child will or will not develop traits of conditions such as Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this may help target useful interventions early on, helping children who are most in need.

Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have been given ethical approval to include testing for this infection in the mothers and children participating in the study. This may provide an opportunity to better understand how mother and baby respond to infections. The investigators particularly welcome mothers who have had a positive COVID-19 test during their pregnancy to join the study.

Registry
clinicaltrials.gov
Start Date
April 5, 2013
End Date
May 2028
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Grainne McAlonan

Principal Investigator

King's College London

Eligibility Criteria

Inclusion Criteria

  • Pregnant mothers with and without confirmed COVID-19
  • Infants with and without an immediate family history of Autism Spectrum and neurodevelopmental conditions
  • Based in England, UK

Exclusion Criteria

  • based on further screening

Outcomes

Primary Outcomes

Neurodevelopmental Outcomes

Time Frame: 3-4 years of age

Study Sites (1)

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