Menu
Recruiting NCT04443179

Brain Imaging in Babies Study

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Conditions, COVID-19. Basic parameters: 16 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Brain Imaging and Infant Development

Overview

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.

Primary outcome measures

  • Neurodevelopmental Outcomes [Time frame: 3-4 years of age]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United Kingdom · 1 center
  • King's College London — London

Identifiers

NCT: NCT04443179 · IRAS: 108997, REC 12/LO/2017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗