<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/NCT02968628</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00061973</org_study_id>
    <nct_id>NCT02968628</nct_id>
  </id_info>
  <brief_title>Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)</brief_title>
  <official_title>Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alterations in the intrauterine environment can have profound effects on fetal development.&#xD;
      Diabetes during gestation results in multiple deleterious short-term outcome differences, and&#xD;
      is correlated with long-term developmental deficits. Multiple studies, in neonates through&#xD;
      school-aged children, have demonstrated differences in language, attention and psychomotor&#xD;
      development in offspring of diabetic pregnancies. Neonatal EEG is a promising and&#xD;
      non-invasive tool for assessment of abnormal brain development or &quot;dysmaturity&quot; in this&#xD;
      population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters&#xD;
      change predictably with advancing gestational development and have been used to differentiate&#xD;
      between at risk groups in neonatal studies.&#xD;
&#xD;
      The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of&#xD;
      diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is&#xD;
      documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of&#xD;
      aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal brain&#xD;
      development.&#xD;
&#xD;
      The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to&#xD;
      gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation&#xD;
      whose mothers were recommended treatment with either insulin or an oral glycemic agent. Video&#xD;
      EEG recording will be planned for approximately 60 minutes and obtained between 24 hours and&#xD;
      5 days of life during birth hospitalization. Additional data will be extracted from maternal&#xD;
      and neonatal medical records and a maternal questionnaire.&#xD;
&#xD;
      In addition to evaluating the measures of cEEG and aEEG, this project will establish a&#xD;
      research cohort. A subsequent study involving developmental evaluations will allow for&#xD;
      correlation of EEG results with long-term outcomes. The ability to identify those at risk at&#xD;
      birth would provide the opportunity to intervene in order to mitigate outcome differences,&#xD;
      particularly in language development. More significantly, we hope to establish neonatal CNS&#xD;
      outcome measures for future diabetic pregnancy intervention studies. .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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>Maximum Interburst Interval on cEEG</measure>
    <time_frame>Single EEG between 24 hours of life and 5 days of life</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lower Margin Amplitude on aEEG</measure>
    <time_frame>Single EEG between 24 hours of life and 5 days of life</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Delta Brushes on cEEG</measure>
    <time_frame>Single EEG between 24 hours of life and 5 days of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bandwidth on aEEG</measure>
    <time_frame>Single EEG between 24 hours of life and 5 days of life</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">39</enrollment>
  <condition>Diabetes in Pregnancy</condition>
  <condition>Diabetes, Gestational</condition>
  <condition>Infant, Newborn, Diseases</condition>
  <condition>Perinatal Disorders of Growth and Development</condition>
  <arm_group>
    <arm_group_label>Cases: Infants of Diabetic Mothers</arm_group_label>
    <description>Cases: Neonates born at or over 35 weeks gestation whose mother's were recommended to receive medication for diabetes during pregnancy. This includes pre-gestational and gestational diabetics.&#xD;
Interventions:&#xD;
Video Electroencephalogram (EEG)&#xD;
Point-of Care Blood Sugar Testing&#xD;
Medical Record Data Extraction&#xD;
Maternal Questionnaire</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Controls: Neonates born at or over 35 weeks gestation whose mother's had normal glycemic control testing during pregnancy.&#xD;
Interventions:&#xD;
Video Electroencephalogram (EEG)&#xD;
Point-of Care Blood Sugar Testing&#xD;
Medical Record Data Extraction&#xD;
Maternal Questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video Electroencephalogram (EEG)</intervention_name>
    <description>Single neonatal video EEG at 24 hrs to 5 days of life during birth hospitalization. Neonatal scalp leads, respiratory and nasal leads. Approximately 60 minute recording.</description>
    <arm_group_label>Cases: Infants of Diabetic Mothers</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Point-of Care Blood Sugar Testing</intervention_name>
    <description>One-time heel-stick point-of-care blood sugar testing at time of EEG.</description>
    <arm_group_label>Cases: Infants of Diabetic Mothers</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Record Data Extraction</intervention_name>
    <description>Medical record data extraction from both maternal obstetric and neonatal medical record for variables known to impact EEG and neurodevelopmental outcomes.</description>
    <arm_group_label>Cases: Infants of Diabetic Mothers</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maternal Questionnaire</intervention_name>
    <description>One-time maternal questionnaire related to smoking practices, ETOH consumption, level of education, and body mass index.</description>
    <arm_group_label>Cases: Infants of Diabetic Mothers</arm_group_label>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be a convenience sample, comprised of singleton neonates born at&#xD;
        or after 35 weeks post-menstrual age at the University of Rochester Medical Center (URMC).&#xD;
        Cases will be infants of mothers with either a diagnoses of pre-gestational diabetes or&#xD;
        gestational diabetes whose provider recommends treatment with insulin or oral glycemic&#xD;
        agents. Controls will be neonates whose mothers had normal glucose testing during gestation&#xD;
        and pre-pregnancy BMI of &lt;30. All subjects will be otherwise healthy, as defined by the&#xD;
        exclusion criteria. There is no intended racial, ethnic or gender distribution of these&#xD;
        neonates.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;/= 35 weeks post-menstrual age at delivery&#xD;
&#xD;
          -  Dating by, or consistent with, 1st trimester ultrasound&#xD;
&#xD;
          -  Mother able to communicate in oral and written English&#xD;
&#xD;
          -  Available maternal obstetric record and medication history&#xD;
&#xD;
          -  Singleton gestation&#xD;
&#xD;
          -  Delivery at URMC attended by obstetric staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Maternal Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis by obstetrician of intrauterine growth restriction (IUGR)&#xD;
&#xD;
          -  Documentation in medical record of daily maternal cigarette smoking during 2nd or 3rd&#xD;
             trimester&#xD;
&#xD;
          -  Chronic maternal sedative or opiate use (&gt;weekly use)&#xD;
&#xD;
          -  Recreational opiate use or addiction&#xD;
&#xD;
          -  Cocaine or amphetamine use during pregnancy&#xD;
&#xD;
          -  ETOH abuse or concern for abuse during pregnancy (&gt;weekly use)&#xD;
&#xD;
          -  Other maternal conditions that may compromise fetus&#xD;
&#xD;
          -  Psychiatric medications beyond isolated SSRI use&#xD;
&#xD;
          -  Anti-epileptic drugs (AEDs) during gestation&#xD;
&#xD;
          -  Magnesium exposure within 3 days of delivery&#xD;
&#xD;
        Neonatal Exclusion Criteria:&#xD;
&#xD;
          -  Blood gas pH of less than 7.1, if obtained (cord or any prior to EEG)&#xD;
&#xD;
          -  Apgar less than 8 at 5 min&#xD;
&#xD;
          -  CNS malformations, seizures, subgaleal or intracranial bleeds&#xD;
&#xD;
          -  Cardiac anomalies except asymptomatic small-moderate VSD, ASD, or PDA&#xD;
&#xD;
          -  Clinically significant malformations or chromosomal anomalies&#xD;
&#xD;
          -  Small-for-gestational age (&lt;10th % on Fenton growth curve)&#xD;
&#xD;
          -  Respiratory distress ever requiring intubation or requiring CPAP support &gt; 48 hours&#xD;
&#xD;
          -  Hemodynamic instability requiring use of pressors or &gt;2 bolus&#xD;
&#xD;
          -  Culture positive sepsis&#xD;
&#xD;
          -  Clinical concern for meningitis or encephalopathy&#xD;
&#xD;
          -  Sedation medication or other conditions/medications affecting CNS function&#xD;
&#xD;
          -  Clinically obtained total bilirubin more than 15 on day of EEG&#xD;
&#xD;
          -  Scalp injury preventing placement of EEG leads&#xD;
&#xD;
          -  Point-of-care testing (POCT) glucose &lt;45 at time of EEG&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Hours</minimum_age>
    <maximum_age>120 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura M Price, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronnie Guillet, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 26, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Infant, Newborn, Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02968628
org study id: RSRB00061973
nct id: NCT02968628
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Alterations in the intrauterine environment can have profound effects on fetal development.
      Diabetes during gestation results in multiple deleterious short-term outcome differences, and
      is correlated with long-term developmental deficits. Multiple studies, in neonates through
      school-aged children, have demonstrated differences in language, attention and psychomotor
      development in offspring of diabetic pregnancies. Neonatal EEG is a promising and
      non-invasive tool for assessment of abnormal brain development or "dysmaturity" in this
      population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters
      change predictably with advancing gestational development and have been used to differentiate
      between at risk groups in neonatal studies.

      The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of
      diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is
      documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of
      aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal brain
      development.

      The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to
      gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation
      whose mothers were recommended treatment with either insulin or an oral glycemic agent. Video
      EEG recording will be planned for approximately 60 minutes and obtained between 24 hours and
      5 days of life during birth hospitalization. Additional data will be extracted from maternal
      and neonatal medical records and a maternal questionnaire.

      In addition to evaluating the measures of cEEG and aEEG, this project will establish a
      research cohort. A subsequent study involving developmental evaluations will allow for
      correlation of EEG results with long-term outcomes. The ability to identify those at risk at
      birth would provide the opportunity to intervene in order to mitigate outcome differences,
      particularly in language development. More significantly, we hope to establish neonatal CNS
      outcome measures for future diabetic pregnancy intervention studies. .
observational model: Case-Control
time perspective: Prospective
measure: Maximum Interburst Interval on cEEG
time frame: Single EEG between 24 hours of life and 5 days of life
measure: Lower Margin Amplitude on aEEG
time frame: Single EEG between 24 hours of life and 5 days of life
measure: Number of Delta Brushes on cEEG
time frame: Single EEG between 24 hours of life and 5 days of life
measure: Bandwidth on aEEG
time frame: Single EEG between 24 hours of life and 5 days of life
arm group label: Cases: Infants of Diabetic Mothers
description: Cases: Neonates born at or over 35 weeks gestation whose mother's were recommended to receive medication for diabetes during pregnancy. This includes pre-gestational and gestational diabetics.
Interventions:
Video Electroencephalogram (EEG)
Point-of Care Blood Sugar Testing
Medical Record Data Extraction
Maternal Questionnaire
arm group label: Controls
description: Controls: Neonates born at or over 35 weeks gestation whose mother's had normal glycemic control testing during pregnancy.
Interventions:
Video Electroencephalogram (EEG)
Point-of Care Blood Sugar Testing
Medical Record Data Extraction
Maternal Questionnaire
intervention type: Other
intervention name: Video Electroencephalogram (EEG)
description: Single neonatal video EEG at 24 hrs to 5 days of life during birth hospitalization. Neonatal scalp leads, respiratory and nasal leads. Approximately 60 minute recording.
arm group label: Cases: Infants of Diabetic Mothers
arm group label: Controls
intervention type: Other
intervention name: Point-of Care Blood Sugar Testing
description: One-time heel-stick point-of-care blood sugar testing at time of EEG.
arm group label: Cases: Infants of Diabetic Mothers
arm group label: Controls
intervention type: Other
intervention name: Medical Record Data Extraction
description: Medical record data extraction from both maternal obstetric and neonatal medical record for variables known to impact EEG and neurodevelopmental outcomes.
arm group label: Cases: Infants of Diabetic Mothers
arm group label: Controls
intervention type: Other
intervention name: Maternal Questionnaire
description: One-time maternal questionnaire related to smoking practices, ETOH consumption, level of education, and body mass index.
arm group label: Cases: Infants of Diabetic Mothers
arm group label: Controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 24 Hours
maximum age: 120 Hours
healthy volunteers: Accepts Healthy Volunteers
last name: Laura M Price, MD
role: Principal Investigator
affiliation: University of Rochester
last name: Ronnie Guillet, MD, PhD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Infant, Newborn, Diseases
mesh term: Diabetes Mellitus
sharing ipd: No