Indoor Air Pollution (IAP) Carriage Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Medical Research Council Unit, The Gambia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Medical Research Council Unit, The Gambia
ClinicalTrials.gov Identifier:
NCT01660659
First received: May 18, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

Personal exposure to Indoor Air Pollution (IAP) is a known risk factor of severe pneumonia, which is the number one killer of children under five in developing countries. The main source of IAP in developing countries is cooking fires, with an estimated 3 billion people still reliant on biomass stoves for their daily cooking. This study will test the effectiveness of an intervention aimed to reduce IAP, as well as help to quantify the relationship between exposure (IAP) and infection (pneumococcal carriage).

In Phase I (adjunct pilot study L2010.99), 3 fuels and 5 stoves were tested to measure harmful pollutant emissions. The preliminary results showed that the largest difference was found in the fuels (briquettes cleaner than wood), with a smaller difference found between a couple of the improved stoves and the traditional 3-stone. Re-testing of selected stove/fuel combinations to confirm findings has just been completed. Phase II (this proposal) will test the biomass briquettes in a randomized clinical trial to measure actual IAP reductions in households. A proof of concept pneumococcal survey will also be conducted as a secondary study to see whether reduced exposure to IAP affects pneumococcal carriage in babies and mothers


Condition Intervention
Pneumococcal Carriage
Particulate Matter
Device: Biomass Briquettes and Rocket stove

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Use of Biomass Briquettes: Its Effect on Indoor Air Pollution and on Pneumococcal Nasopharyngeal Carriage. A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Medical Research Council Unit, The Gambia:

Primary Outcome Measures:
  • IAP Carriage Study [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    1. Integrated PM2.5 concentrations (48 hour measurements in each kitchen) Integrated PM2.5 concentrations will be measured using gravimetric Casella and SKC pumps, cyclones, and Teflon filters. The pumps will run one minute on, 5 minutes off, for 48 continuous hours in each of the participating cookhouses. These integrated measurements will allow us to compare the emissions from briquettes and firewood.

    The measurements will take place at a random time during the 16 week invention period



Secondary Outcome Measures:
  • IAP Carriage Study [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To measure the prevalence of pneumococcal carriage in both study arms. These surveys will occur at the start of the study (before the intervention) to capture the baseline measurement, and at the end of the study (after the 16 weeks of intervention), to see whether reduced exposure to PMs affects pneumococcal carriage in the mothers and babies


Estimated Enrollment: 500
Study Start Date: January 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cooking with Biomass Briquettes and Rocket Stove
cooking with Biomass Briquettes and Rocket Stove
Device: Biomass Briquettes and Rocket stove
Biomass briquettes are made from dried peanut shells. Rocket stoves were designed to efficiently burn the briquettes
No Intervention: standard cooking
standard way of cooking

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child between 2 to 8 months of age at start of the study (1st pneumococcal swab)
  • residing within the catchment area
  • the mother relies only on wood and the 3-stone stove for all her cooking
  • the mother will cook in an indoor kitchen only (not outside; 4 walls with a roof)
  • written informed consent

Exclusion Criteria:

  • will be traveling from their home during the following 6 months
  • already involved in another study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660659

Locations
Gambia
Medical Research Council Unit
Fajara, Gambia
Sponsors and Collaborators
Medical Research Council Unit, The Gambia
Investigators
Principal Investigator: Teresa Litchfield Medical Research Council Unit, The Gambia
  More Information

No publications provided

Responsible Party: Medical Research Council Unit, The Gambia
ClinicalTrials.gov Identifier: NCT01660659     History of Changes
Other Study ID Numbers: SCC 1284
Study First Received: May 18, 2012
Last Updated: August 6, 2012
Health Authority: Gambia: Ethics Committee

Keywords provided by Medical Research Council Unit, The Gambia:
Indoor air pollution
pneumococcal carriage

ClinicalTrials.gov processed this record on October 16, 2014