Oxidant ImbalanceNCT02200289
In Utero Household Air Pollution Exposure and Lung Development in Ghana
An observational study of Oxidant Imbalance and Pulmonary Function, run by Icahn School of Medicine at Mount Sinai at 1 site in Ghana.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidant Imbalance, Pulmonary Function
- How many people
- 400 participants
- Where
- 1 siteGhana
- Study dates
- Oct 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mother-infant pairs are recruited from the Ghana Randomized Air Pollution and Health Study (GRAPHS). GRAPHS participants are from the Kintampo Health Research catchment area in rural Ghana, which comprises a population of 146,000 people.
Who may be able to join
- Women
- Primarily deliver at one of four KHRC birth facilities
- Pregnant with a singleton fetus
- Pregnancy of gestational age less than 24 weeks
Who cannot join
- Pregnant with more than a singleton fetus (twins, etc)
- Pregnancy beyond 24 weeks gestation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Utero Biomass Smoke Exposure, Pro-oxidant/Antioxidant Imbalance and Lung Function in Rural Ghana
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.
Read the detailed description
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.
- Conditions
- Oxidant Imbalance, Pulmonary Function
- Keywords
- Birth cohort, Ghana, Biomass, Cook stove, Oxidative stress, Lung development
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 |
|---|---|---|
| Mother-infant pairs | Mother-infant pairs from the GRAPHS birth cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidant imbalance
at infant delivery
Measured: Day 1
Secondary outcomes (1)
Lung function
Infant age less than or equal to one month
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidant ImbalanceStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Kintampo Health Research Centre, Ghana
- Responsible party
- Sponsor
- Investigators
- Alison Lee, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200289
- Sponsor's protocol ID
- GCO 14-1215
- Status last verified
- Nov 2015
- First submitted
- 23 Jul 2014
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Utero Biomass Smoke Exposure, Pro-oxidant/Antioxidant Imbalance and Lung Function in Rural Ghana
- ClinicalTrials.gov ID
- NCT02200289
- Acronym / sponsor ID
- GCO 14-1215
- Conditions
- Oxidant Imbalance, Pulmonary Function
- Keywords
- Birth cohort, Ghana, Biomass, Cook stove, Oxidative stress, Lung development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Columbia University, Kintampo Health Research Centre, Ghana
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-infant pairs | – | –Mother-infant pairs from the GRAPHS birth cohort study |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mother-infant pairs are recruited from the Ghana Randomized Air Pollution and Health Study (GRAPHS). GRAPHS participants are from the Kintampo Health Research catchment area in rural Ghana, which comprises a population of 146,000 people.
Key inclusion criteria (4 listed)
- Women
- Primarily deliver at one of four KHRC birth facilities
- Pregnant with a singleton fetus
- Pregnancy of gestational age less than 24 weeks
Key exclusion criteria (2 listed)
- Pregnant with more than a singleton fetus (twins, etc)
- Pregnancy beyond 24 weeks gestation
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
Oxidant imbalance
Time frame: Day 1
at infant delivery
1 secondary outcome
Lung function
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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. This study is not recruiting at the moment.
Alison Lee, MD principal investigator
Icahn School of Medicine at Mount Sinai
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 Oxidant Imbalance and Pulmonary Function, run by Icahn School of Medicine at Mount Sinai at 1 site in Ghana.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 Nov 2015. 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 Ghana. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidant imbalance (time frame: Day 1). 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 24 Nov 2015.