Recruitment

Recruitment Status
Completed
Estimated Enrollment
150

Inclusion Criterias

Women
Primarily deliver at one of four KHRC birth facilities
Pregnant with a singleton fetus
...
Women
Primarily deliver at one of four KHRC birth facilities
Pregnant with a singleton fetus
Pregnancy of gestational age less than 24 weeks

Exclusion Criterias

Pregnant with more than a singleton fetus (twins, etc)
Pregnancy beyond 24 weeks gestation
Pregnant with more than a singleton fetus (twins, etc)
Pregnancy beyond 24 weeks gestation

Summary

Conditions
  • Oxidant Imbalance
  • Pulmonary Function
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 125 years
Gender
Only females

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 ...

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.

Inclusion Criterias

Women
Primarily deliver at one of four KHRC birth facilities
Pregnant with a singleton fetus
...
Women
Primarily deliver at one of four KHRC birth facilities
Pregnant with a singleton fetus
Pregnancy of gestational age less than 24 weeks

Exclusion Criterias

Pregnant with more than a singleton fetus (twins, etc)
Pregnancy beyond 24 weeks gestation
Pregnant with more than a singleton fetus (twins, etc)
Pregnancy beyond 24 weeks gestation

Locations

Kintampo
Kintampo

Tracking Information

NCT #
NCT02200289
Collaborators
  • Columbia University
  • Kintampo Health Research Centre, Ghana
Investigators
  • Principal Investigator: Alison Lee, MD Icahn School of Medicine at Mount Sinai
  • Alison Lee, MD Icahn School of Medicine at Mount Sinai