Brain Imaging in Babies Study (BIBS)

Brain Imaging and Infant Development

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Conditions

• Study Type: Observational
• Enrollment (Estimated): 790

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 8AF
    • Recruiting
    • King's College London
    • Contact: Gráinne McAlonan, PhD; Phone Number: 02078480831; Email: grainne.mcalonan@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Community Sample

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Infants a family history of ASD/ADHD
Infants without a family history of ASD/ADHD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neurodevelopmental Outcomes	3-4 years of age

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2013
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
• Other Study ID Numbers: IRAS: 108997, REC 12/LO/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No