In Utero Household Air Pollution Exposure and Lung Development in Ghana

NCT02200289 | Completed

• 1 other identifier: GCO 14-1215
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oxidant Imbalance; Pulmonary Function

Keywords

Birth cohort; Ghana; Biomass; Cook stove; Oxidative stress; Lung development

Outcome Measures

Primary Outcomes (1)

• Oxidant imbalance

  at infant delivery

  Day 1

Secondary Outcomes (1)

• Lung function

  up to 1 month

Study Arms (1)

Mother-infant pairs

Mother-infant pairs from the GRAPHS birth cohort study

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Columbia University: collaborator
• Kintampo Health Research Centre, Ghana: collaborator

Study Sites (1)

Kintampo Health Research Centre

Kintampo, Ghana

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cord blood, placenta

Study Officials

• Alison Lee, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

GH (1)