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Completed

NCT Number: NCT01047696

Randomised Exposure Study of Pollution Indoors and Respiratory Effects

The purpose of this study was to determine whether reduced exposure to indoor air pollution would reduce ALRI incidence in children <18 months of age. Households were randomized to receive a chimney stove (intervention group) or continue using an open fire for cooking and heating (control group).

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Key information

Age range

Up to 18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Lorenzo, Guatemala

About this study

Acute lower respiratory infections (ALRI) are the chief killer of children. Most cases are pneumonia and the majority occur among poor children under five years in developing countries. Poverty might be said to be the primary cause, which manifests as malnutrition, including micro-nutrient deficiencies, and lack of access to medical care. Another attribute of poverty is household indoor air pollution (HAP) from use of unprocessed solid fuels such as biomass (wood, animal dung and crop wastes) and coal in simple stoves. A meta-analysis of published observational studies found that young children exposed to smoke from household solid fuel use had a rate of ALRI twice that of children not exposed or where clean fuels were used. Recent studies have shown similar ALRI risks associated with short-term air pollution measurements and other indicators of exposure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Households were invited to participate in the study if they met the following inclusion criteria:

  • Used only an open fire for cooking and heating
  • Had a pregnant woman or child < 4 months residing in the home
  • Identified as Mam (the regional ethnic group), and had
  • Minimal summer migration (less than 12 weeks per year)

Exclusion criteria

Households were excluded from participating if:

  • The household was already using a chimney stove for cooking
  • There was no child <4 months of age or a pregnant woman residing in the home
  • Seasonal migration required the family to move to another region for more than 12 weeks of the year

Treatment and study plan

Plancha

Device

locally developed chimney stove

Primary outcomes

  1. The primary outcome measure was physician-diagnosed pneumonia in children

    Time frame: Through 18 months of age

Secondary outcomes

  1. Severe (hypoxaemic) and RSV pneumonia

    Time frame: Through 18 months of age

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Universidad del Valle, Guatemala
  • University of Liverpool
  • World Health Organization

Registry information

Official study title

Particulate Air Pollution Exposure and Childhood Acute Respiratory Infections in Guatemala: A Randomized Intervention

Acronym: RESPIRE

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Jan 13, 2010
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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