Autism Spectrum DisorderBIBSNCT04443179
Brain Imaging in Babies Study
An observational study of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by King's College London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Conditions
- How many people
- 790 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2013to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community Sample
Who may be able to join
- 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
Who cannot join
- based on further screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE5 8AF
Gráinne McAlonan, PhD, 02078480831, grainne.mcalonan@kcl.ac.uk
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants a family history of ASD/ADHD | Not described | |
| Infants without a family history of ASD/ADHD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental Outcomes
Measured: 3-4 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start5 Apr 2013
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 790 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Grainne McAlonan, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443179
- Sponsor's protocol ID
- IRAS: 108997, REC 12/LO/2017
- Acronym
- BIBS
- Status last verified
- Mar 2024
- First submitted
- 19 Jun 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging and Infant Development
- ClinicalTrials.gov ID
- NCT04443179
- Acronym / sponsor ID
- BIBS / IRAS: 108997, REC 12/LO/2017
- Conditions
- Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Conditions, COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 790 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 5 Apr 2013 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants a family history of ASD/ADHD | – | – |
| Infants without a family history of ASD/ADHD | – | – |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- based on further screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurodevelopmental Outcomes
Time frame: 3-4 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Related trials for Autism Spectrum Disorder
Recruiting
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Autism Spectrum Disorder, Therapy
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
Active, not recruitingPhase 1
Psilocybin for Treatment-Resistant Depression in Autism
Treatment Resistant Depression, Autism Spectrum Disorder
RecruitingPhase 2
TRIal of PPF3 vs. PlaCEbo in the TReatment of Children and AdolescenTs With NeurOdeveloPmental DisorderS
Autism Disorder
Not yet recruitingObservational study
EEG As a Genetic Selection Lever in Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental Outcomes (time frame: 3-4 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.