Indoor Air Pollution (IAP) Carriage Study

NCT01660659 | Completed

• 1 other identifier: SCC 1284
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumococcal Carriage; Particulate Matter

Keywords

Indoor air pollution; pneumococcal carriage

Outcome Measures

Primary Outcomes (1)

• IAP Carriage Study

  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

  12 months

Secondary Outcomes (1)

• IAP Carriage Study

  12 months

Study Arms (2)

cooking with Biomass Briquettes and Rocket Stove

EXPERIMENTAL

cooking with Biomass Briquettes and Rocket Stove

Device: Biomass Briquettes and Rocket stove

standard cooking

NO INTERVENTION

standard way of cooking

Interventions

Biomass Briquettes and Rocket stove DEVICE

Biomass briquettes are made from dried peanut shells. Rocket stoves were designed to efficiently burn the briquettes

cooking with Biomass Briquettes and Rocket Stove

Eligibility Criteria

• Age: 2 Months - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• will be traveling from their home during the following 6 months
• already involved in another study

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

Medical Research Council Unit

Fajara, The Gambia

Location

Study Officials

• Teresa Litchfield

  Medical Research Council Unit, The Gambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: August 9, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2015
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

TH (1)