<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04443179</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS: 108997, REC 12/LO/2017</org_study_id>
    <nct_id>NCT04443179</nct_id>
  </id_info>
  <brief_title>Brain Imaging in Babies Study</brief_title>
  <acronym>BIBS</acronym>
  <official_title>Brain Imaging and Infant Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of the BIBS Study&#xD;
&#xD;
      The Brain Imaging in Babies study (BIBS) aims to improve understanding of how a baby's brain&#xD;
      develops from before birth, up until 3-4 years of age. Working with children from a variety&#xD;
      of backgrounds and communities, the investigators use a combination of state-of-the-art&#xD;
      diagnostic tools such as MRI scans alongside traditional behavioural assessments to capture&#xD;
      the earliest information on infant brain development.&#xD;
&#xD;
      The focus of the BIBS study&#xD;
&#xD;
      MRI scanning is a safe way of producing detailed images using strong magnetic fields and&#xD;
      radio waves. It does not use X-ray. Along with learning more about brain development in&#xD;
      general, the investigators also try to identify features that may in future help predict&#xD;
      whether a child will or will not develop traits of conditions such as Autism Spectrum&#xD;
      Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD). Long-term, this may help&#xD;
      target useful interventions early on, helping children who are most in need.&#xD;
&#xD;
      Since COVID-19 arrived in the United Kingdom (U.K.) in 2020, the investigators have been&#xD;
      given ethical approval to include testing for this infection in the mothers and children&#xD;
      participating in the study. This may provide an opportunity to better understand how mother&#xD;
      and baby respond to infections. The investigators particularly welcome mothers who have had a&#xD;
      positive COVID-19 test during their pregnancy to join the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 5, 2013</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neurodevelopmental Outcomes</measure>
    <time_frame>3-4 years of age</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">790</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <condition>Neurodevelopmental Conditions</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Infants a family history of ASD/ADHD</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants without a family history of ASD/ADHD</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Community Sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant mothers with and without confirmed COVID-19&#xD;
&#xD;
          -  Infants with and without an immediate family history of Autism Spectrum and&#xD;
             neurodevelopmental conditions&#xD;
&#xD;
          -  Based in England, UK&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  based on further screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE5 8AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gráinne McAlonan, PhD</last_name>
      <phone>02078480831</phone>
      <email>grainne.mcalonan@kcl.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King's College London</investigator_affiliation>
    <investigator_full_name>Dr Grainne McAlonan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04443179
org study id: IRAS: 108997, REC 12/LO/2017
nct id: NCT04443179
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Prospective
measure: Neurodevelopmental Outcomes
time frame: 3-4 years of age
arm group label: Infants a family history of ASD/ADHD
arm group label: Infants without a family history of ASD/ADHD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: King's College London
investigator full name: Dr Grainne McAlonan
investigator title: Principal Investigator
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Autism Spectrum Disorder