Pulmonary Function Clinical Trial
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women - Primarily deliver at one of four KHRC birth facilities - Pregnant with a singleton fetus - Pregnancy of gestational age less than 24 weeks Exclusion Criteria: - Pregnant with more than a singleton fetus (twins, etc) - Pregnancy beyond 24 weeks gestation |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Ghana | Kintampo Health Research Centre | Kintampo |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Columbia University, Kintampo Health Research Centre, Ghana |
Ghana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxidant imbalance | at infant delivery | Day 1 | No |
Secondary | Lung function | Infant age less than or equal to one month | up to 1 month | No |
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