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NCT04443179 Clinical Trial

Brain Imaging in Babies Study

COVID-19 Clinical Trial

— BIBS  

Official title:
Brain Imaging and Infant Development

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04443179
Other study ID # IRAS: 108997, REC 12/LO/2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2013
Est. completion date May 2028

Study information
Verified date March 2024
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 790
Est. completion date May 2028
Est. primary completion date May 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom King's College London London

Sponsors (1)
Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neurodevelopmental Outcomes 3-4 years of age
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