<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/NCT02200289</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 14-1215</org_study_id>
    <nct_id>NCT02200289</nct_id>
  </id_info>
  <brief_title>In Utero Household Air Pollution Exposure and Lung Development in Ghana</brief_title>
  <official_title>In Utero Biomass Smoke Exposure, Pro-oxidant/Antioxidant Imbalance and Lung Function in Rural Ghana</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kintampo Health Research Centre, Ghana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Household air pollution from cook stoves using solid fuels dominates total population air&#xD;
      pollution exposures. Females and young children are disproportionately affected as they&#xD;
      either perform or are present for the majority of cooking activities. Worldwide, household&#xD;
      air pollution is responsible for 1.6 million premature deaths annually, largely secondary to&#xD;
      respiratory tract infections, and 2.7% of worldwide disability-adjusted life years. Children&#xD;
      that survive childhood are not free from disease; the WHO estimates that 35% of COPD cases&#xD;
      worldwide are secondary to household air pollution. Reducing female and infant morbidity and&#xD;
      mortality related to household air pollution secondary to biomass smoke exposure is a&#xD;
      top-priority public health goal.&#xD;
&#xD;
      We hypothesize that in utero biomass smoke exposure results in a fetal oxidant imbalance,&#xD;
      which negatively impacts lung development. We will leverage the success of the Ghana&#xD;
      Randomized Air Pollution and Health Study, a randomized cook stove intervention trial of&#xD;
      1,415 mother-infant pairs, to examine the impact of maternal household air pollution exposure&#xD;
      on cord blood oxidant imbalance and infant pulmonary function. We aim to enroll at least 150&#xD;
      infants, analyze cord blood samples for markers of oxidant imbalance and perform infant&#xD;
      pulmonary function testing. Cord blood will also be prepared for future immune, hormonal and&#xD;
      epigenetic testing. This study will allow us to consider interventions, such as maternal&#xD;
      antioxidant dietary supplementation during pregnancy, to compliment existing cook stove&#xD;
      interventions and reduce household air pollution-related morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will be nested within the Ghana Randomized Air Pollution and Health Study&#xD;
      (GRAPHS) to investigate oxidant imbalance and pulmonary function in infants exposed to in&#xD;
      utero household air pollution.&#xD;
&#xD;
      GRAPHS is a birth cohort study examining the impact of reduced maternal household air&#xD;
      pollution exposure on birth outcomes and incident infant pneumonia. Mother-infant pairs are&#xD;
      recruited from the Kintampo Health Research Centre (KHRC) catchment area in rural Ghana,&#xD;
      which comprises a population of 146,000 people. 1,415 nonsmoking women who primarily deliver&#xD;
      at one of four KHRC birth facilities and are pregnant with a singleton fetus of gestational&#xD;
      age less than 24 weeks are eligible for participation. After enrollment, women are randomized&#xD;
      to a no-emission liquid petroleum gas (LPG) stove, a low-emission BioLite cook stove or&#xD;
      control (high-emission) arms and undergo four 72-hour carbon monoxide (CO) and/or particulate&#xD;
      matter (PM) prenatal exposure monitoring sessions. Birth weights and outcomes are recorded&#xD;
      and a placenta sample is stored in formalin for future analyses. The infants are followed&#xD;
      with CO and PM exposure monitoring sessions at 1, 3 and 9 months of age and weekly&#xD;
      surveillance for incident respiratory disease.&#xD;
&#xD;
      For the proposed study, we will recruit and consent GRAPHS mother-infant pairs. Venous cord&#xD;
      blood and placenta samples will be collected following placenta delivery. Cord blood will be&#xD;
      placed on IsoRack cool packs designed to maintain samples at 0°C for up to 6 hours. Cord&#xD;
      blood samples will be processed for biomarkers of oxidant imbalance and for future study,&#xD;
      including but not limited to immune function, hormonal balance and epigenetic analyses. After&#xD;
      initial processing, samples will be frozen at -80°C until oxidant analyses are performed&#xD;
      using commercially available reagent kits and protocols.&#xD;
&#xD;
      When the infant is one month old or younger, trained study personnel will perform noninvasive&#xD;
      pulmonary function testing (PFT) using the Medispirit Whistler Lung Function Measurement&#xD;
      Instrument (LFMI) in accordance with ATS/ERS guidelines. The Medispirit Whistler LFMI is a&#xD;
      lightweight and portable device that allows non-invasive PFTs to be performed in the infant's&#xD;
      home. The Whistler LFMI flow measurement is ultrasonic and therefore does not need to be&#xD;
      calibrated. The infant will be held with his/her head in a stable position until s/he is&#xD;
      breathing quietly or asleep. A sterile, single-use, transparent facemask that does not&#xD;
      interfere with normal breathing will be placed over the infant's mouth and nose. Tidal flow&#xD;
      volume loops will be recorded and single occlusion test will be used to determine the ratio&#xD;
      of time to reach peak expiratory flow to total expiratory time, compliance and resistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oxidant imbalance</measure>
    <time_frame>Day 1</time_frame>
    <description>at infant delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung function</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Infant age less than or equal to one month</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Oxidant Imbalance</condition>
  <condition>Pulmonary Function</condition>
  <arm_group>
    <arm_group_label>Mother-infant pairs</arm_group_label>
    <description>Mother-infant pairs from the GRAPHS birth cohort study</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cord blood, placenta&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Mother-infant pairs are recruited from the Ghana Randomized Air Pollution and Health Study&#xD;
        (GRAPHS). GRAPHS participants are from the Kintampo Health Research catchment area in rural&#xD;
        Ghana, which comprises a population of 146,000 people.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Primarily deliver at one of four KHRC birth facilities&#xD;
&#xD;
          -  Pregnant with a singleton fetus&#xD;
&#xD;
          -  Pregnancy of gestational age less than 24 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant with more than a singleton fetus (twins, etc)&#xD;
&#xD;
          -  Pregnancy beyond 24 weeks gestation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kintampo Health Research Centre</name>
      <address>
        <city>Kintampo</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>November 23, 2015</last_update_submitted>
  <last_update_submitted_qc>November 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Birth cohort</keyword>
  <keyword>Ghana</keyword>
  <keyword>Biomass</keyword>
  <keyword>Cook stove</keyword>
  <keyword>Oxidative stress</keyword>
  <keyword>Lung development</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/NCT02200289
org study id: GCO 14-1215
nct id: NCT02200289
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Household air pollution from cook stoves using solid fuels dominates total population air
      pollution exposures. Females and young children are disproportionately affected as they
      either perform or are present for the majority of cooking activities. Worldwide, household
      air pollution is responsible for 1.6 million premature deaths annually, largely secondary to
      respiratory tract infections, and 2.7% of worldwide disability-adjusted life years. Children
      that survive childhood are not free from disease; the WHO estimates that 35% of COPD cases
      worldwide are secondary to household air pollution. Reducing female and infant morbidity and
      mortality related to household air pollution secondary to biomass smoke exposure is a
      top-priority public health goal.

      We hypothesize that in utero biomass smoke exposure results in a fetal oxidant imbalance,
      which negatively impacts lung development. We will leverage the success of the Ghana
      Randomized Air Pollution and Health Study, a randomized cook stove intervention trial of
      1,415 mother-infant pairs, to examine the impact of maternal household air pollution exposure
      on cord blood oxidant imbalance and infant pulmonary function. We aim to enroll at least 150
      infants, analyze cord blood samples for markers of oxidant imbalance and perform infant
      pulmonary function testing. Cord blood will also be prepared for future immune, hormonal and
      epigenetic testing. This study will allow us to consider interventions, such as maternal
      antioxidant dietary supplementation during pregnancy, to compliment existing cook stove
      interventions and reduce household air pollution-related morbidity and mortality.
The proposed study will be nested within the Ghana Randomized Air Pollution and Health Study
      (GRAPHS) to investigate oxidant imbalance and pulmonary function in infants exposed to in
      utero household air pollution.

      GRAPHS is a birth cohort study examining the impact of reduced maternal household air
      pollution exposure on birth outcomes and incident infant pneumonia. Mother-infant pairs are
      recruited from the Kintampo Health Research Centre (KHRC) catchment area in rural Ghana,
      which comprises a population of 146,000 people. 1,415 nonsmoking women who primarily deliver
      at one of four KHRC birth facilities and are pregnant with a singleton fetus of gestational
      age less than 24 weeks are eligible for participation. After enrollment, women are randomized
      to a no-emission liquid petroleum gas (LPG) stove, a low-emission BioLite cook stove or
      control (high-emission) arms and undergo four 72-hour carbon monoxide (CO) and/or particulate
      matter (PM) prenatal exposure monitoring sessions. Birth weights and outcomes are recorded
      and a placenta sample is stored in formalin for future analyses. The infants are followed
      with CO and PM exposure monitoring sessions at 1, 3 and 9 months of age and weekly
      surveillance for incident respiratory disease.

      For the proposed study, we will recruit and consent GRAPHS mother-infant pairs. Venous cord
      blood and placenta samples will be collected following placenta delivery. Cord blood will be
      placed on IsoRack cool packs designed to maintain samples at 0°C for up to 6 hours. Cord
      blood samples will be processed for biomarkers of oxidant imbalance and for future study,
      including but not limited to immune function, hormonal balance and epigenetic analyses. After
      initial processing, samples will be frozen at -80°C until oxidant analyses are performed
      using commercially available reagent kits and protocols.

      When the infant is one month old or younger, trained study personnel will perform noninvasive
      pulmonary function testing (PFT) using the Medispirit Whistler Lung Function Measurement
      Instrument (LFMI) in accordance with ATS/ERS guidelines. The Medispirit Whistler LFMI is a
      lightweight and portable device that allows non-invasive PFTs to be performed in the infant's
      home. The Whistler LFMI flow measurement is ultrasonic and therefore does not need to be
      calibrated. The infant will be held with his/her head in a stable position until s/he is
      breathing quietly or asleep. A sterile, single-use, transparent facemask that does not
      interfere with normal breathing will be placed over the infant's mouth and nose. Tidal flow
      volume loops will be recorded and single occlusion test will be used to determine the ratio
      of time to reach peak expiratory flow to total expiratory time, compliance and resistance.
observational model: Cohort
time perspective: Prospective
measure: Oxidant imbalance
time frame: Day 1
description: at infant delivery
measure: Lung function
time frame: up to 1 month
description: Infant age less than or equal to one month
arm group label: Mother-infant pairs
description: Mother-infant pairs from the GRAPHS birth cohort study
Cord blood, placenta
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alison Lee, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: Ghana
responsible party type: Sponsor