Brain Imaging in Babies Study

NCT04443179 | Recruiting

• 1 other identifier: IRAS: 108997, REC 12/LO/2017
• Study Type: observational
• Target: 790
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Conditions; COVID-19

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental Outcomes

  3-4 years of age

Study Arms (2)

Infants a family history of ASD/ADHD

Infants without a family history of ASD/ADHD

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• 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

You may not qualify if:

• based on further screening

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; COVID-19

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: April 5, 2013
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

GB (1)