<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/NCT02184780</url>
  </required_header>
  <id_info>
    <org_study_id>CIRB/2013/644/D</org_study_id>
    <nct_id>NCT02184780</nct_id>
  </id_info>
  <brief_title>Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood</brief_title>
  <acronym>PANO</acronym>
  <official_title>Impact of Perinatal Anaesthesia and Analgesia on Neurocognitive Outcomes in Early Childhood (PANO Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KK Women's and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Singapore Institute for Clinical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KK Women's and Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the impact of perinatal exposure to anaesthesia and analgesia on&#xD;
      neurocognitive outcomes in early childhood by analyzing neurocognitive data already obtained&#xD;
      from the local prospective observational cohort study: Growing up in Singapore Towards&#xD;
      Healthy Outcomes (GUSTO).&#xD;
&#xD;
      We hypothesize that:&#xD;
&#xD;
        1. Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive&#xD;
           outcomes at 6, 18, 24 and 36 months.&#xD;
&#xD;
        2. Maternal anxiety and depression during the antenatal and post-partum period is&#xD;
           associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early exposure to general anesthesia is associated long-term neurocognitive and behavioral&#xD;
      abnormalities. However the impact of obstetric and perinatal exposure to anaesthesia and&#xD;
      analgesia on long term neurocognitive outcomes in the absence of concurrent events (e.g.&#xD;
      fetal hypoxia) is unknown. We aim to determine the impact of perinatal exposure to&#xD;
      anaesthesia and analgesia on neurocognitive outcomes in early childhood by analyzing&#xD;
      information already obtained from the local prospective observational cohort study: Growing&#xD;
      up in Singapore Towards Healthy Outcomes (GUSTO). GUSTO is a large prospective cohort trial&#xD;
      currently conducted in Singapore examining maternal and neonatal outcomes including&#xD;
      metabolic, psychological and developmental outcomes.&#xD;
&#xD;
      Information on infants' neurocognitive outcomes up to 24 months old are already available and&#xD;
      we will correlate these outcomes to&#xD;
&#xD;
        1. The infants' perinatal exposure to anaesthesia and analgesia, as obtained from hospital&#xD;
           records, and&#xD;
&#xD;
        2. Maternal anxiety and depression, as observed from analysis of questionnaires already&#xD;
           available from GUSTO.&#xD;
&#xD;
      We hypothesize that:&#xD;
&#xD;
        1. Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive&#xD;
           outcomes at 6, 18, 24 and 36 months.&#xD;
&#xD;
        2. Maternal anxiety and depression during the antenatal and post-partum period is&#xD;
           associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neurocognitive score</measure>
    <time_frame>24 months of age</time_frame>
    <description>Composite Bayley-III Scores in the following domains tested at 24 months of age (cognitive, language, motor, socio-emotional, general adaptability) These scores are already available from the existing cohort and will be correlated with perinatal exposure to anaesthesia and analgesia and maternal anxiety and depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive Score (Deferred Imitation)</measure>
    <time_frame>6, 18 and 24 months</time_frame>
    <description>Neurocognitive scores as measured by deferred imitation, a test of memory and attention. These scores are already available from the existing cohort and will be correlated with perinatal exposure to anaesthesia and analgesia and maternal anxiety and depression.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">468</enrollment>
  <condition>Anaesthesia</condition>
  <condition>Neurodevelopment</condition>
  <arm_group>
    <arm_group_label>GUSTO Neurocognitive Cohort</arm_group_label>
    <description>This study involves retrospective analysis of data from an existing cohort of 600 infants who were enrolled in the neurocognitve arm of the GUSTO study (Growing up in Singapore Towards Healthy Outcomes). GUSTO is a prospective observational cohort study done in Singapore, where subjects were followed up from in-utero up to 36 months of age and beyond. The infants have already undergone a rigorous battery of neurocognitive tests at 6, 18, 24 and 36 months of age and their detailed demographic and medical information are available.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study involves retrospective analysis of data from an existing cohort of 600 infants&#xD;
        who were enrolled in the neurocognitve arm of the GUSTO study (Growing up in Singapore&#xD;
        Towards Healthy Outcomes). GUSTO is a prospective observational cohort study done in&#xD;
        Singapore, where subjects were followed up from in-utero up to 36 months of age and beyond.&#xD;
        The infants have already undergone a rigorous battery of neurocognitive tests at 6, 18, 24&#xD;
        and 36 months of age and their detailed demographic and medical information are available.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Infants who are enrolled in the neurocognitve arm of the GUSTO study (Growing up in&#xD;
        Singapore Towards Healthy Outcomes).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        No information available on previous exposure (maternal exposure in utero, perinatal and&#xD;
        postnatal exposure) to general anaesthesia, spinal or epidural anaesthesia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Choon L Bong, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>KK Women's and Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KK Women's and Children's Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>229899</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neurodevelopment</keyword>
  <keyword>General Anaesthesia</keyword>
  <keyword>Infants</keyword>
  <keyword>Epidural</keyword>
  <keyword>Spinal</keyword>
  <keyword>Anxiety and depression</keyword>
  <!-- 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/NCT02184780
org study id: CIRB/2013/644/D
nct id: NCT02184780
lead sponsor: 
collaborator: 
has dmc: No
This study aims to determine the impact of perinatal exposure to anaesthesia and analgesia on
      neurocognitive outcomes in early childhood by analyzing neurocognitive data already obtained
      from the local prospective observational cohort study: Growing up in Singapore Towards
      Healthy Outcomes (GUSTO).

      We hypothesize that:

        1. Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive
           outcomes at 6, 18, 24 and 36 months.

        2. Maternal anxiety and depression during the antenatal and post-partum period is
           associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.
Early exposure to general anesthesia is associated long-term neurocognitive and behavioral
      abnormalities. However the impact of obstetric and perinatal exposure to anaesthesia and
      analgesia on long term neurocognitive outcomes in the absence of concurrent events (e.g.
      fetal hypoxia) is unknown. We aim to determine the impact of perinatal exposure to
      anaesthesia and analgesia on neurocognitive outcomes in early childhood by analyzing
      information already obtained from the local prospective observational cohort study: Growing
      up in Singapore Towards Healthy Outcomes (GUSTO). GUSTO is a large prospective cohort trial
      currently conducted in Singapore examining maternal and neonatal outcomes including
      metabolic, psychological and developmental outcomes.

      Information on infants' neurocognitive outcomes up to 24 months old are already available and
      we will correlate these outcomes to

        1. The infants' perinatal exposure to anaesthesia and analgesia, as obtained from hospital
           records, and

        2. Maternal anxiety and depression, as observed from analysis of questionnaires already
           available from GUSTO.

      We hypothesize that:

        1. Perinatal exposure to anaesthesia and analgesia is associated with poorer neurocognitive
           outcomes at 6, 18, 24 and 36 months.

        2. Maternal anxiety and depression during the antenatal and post-partum period is
           associated with poorer neurocognitive outcomes at 6, 18 24 and 36 months.
observational model: Cohort
time perspective: Retrospective
measure: Neurocognitive score
time frame: 24 months of age
description: Composite Bayley-III Scores in the following domains tested at 24 months of age (cognitive, language, motor, socio-emotional, general adaptability) These scores are already available from the existing cohort and will be correlated with perinatal exposure to anaesthesia and analgesia and maternal anxiety and depression.
measure: Neurocognitive Score (Deferred Imitation)
time frame: 6, 18 and 24 months
description: Neurocognitive scores as measured by deferred imitation, a test of memory and attention. These scores are already available from the existing cohort and will be correlated with perinatal exposure to anaesthesia and analgesia and maternal anxiety and depression.
arm group label: GUSTO Neurocognitive Cohort
description: This study involves retrospective analysis of data from an existing cohort of 600 infants who were enrolled in the neurocognitve arm of the GUSTO study (Growing up in Singapore Towards Healthy Outcomes). GUSTO is a prospective observational cohort study done in Singapore, where subjects were followed up from in-utero up to 36 months of age and beyond. The infants have already undergone a rigorous battery of neurocognitive tests at 6, 18, 24 and 36 months of age and their detailed demographic and medical information are available.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 4 Years
healthy volunteers: No
last name: Choon L Bong, MBChB
role: Principal Investigator
affiliation: KK Women's and Children's Hospital
facility: 
country: Singapore
responsible party type: Sponsor