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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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