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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01660659
Other study ID # SCC 1284
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date August 2015

Study information

Verified date May 2018
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Biomass Briquettes and Rocket stove
Biomass briquettes are made from dried peanut shells. Rocket stoves were designed to efficiently burn the briquettes

Locations

Country Name City State
Gambia Medical Research Council Unit Fajara

Sponsors (1)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Gambia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 IAP Carriage Study 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 12 months
See also
  Status Clinical Trial Phase
Completed NCT00894764 - The Study of Chest Infections in Infants Living in a Refugee Camp on the Thai-Burmese Border N/A
Not yet recruiting NCT06373328 - Post Pandemic Pneumococcal Carriage Among Children and Adults
Active, not recruiting NCT05175014 - Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV) Phase 4