Acute Lower Respiratory IllnessPhase 3NCT00786877
Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal
A Phase 3 study testing Improved biomass cookstove with exterior ventilation and Phase 2 intervention arm (LPG stove) in people with Acute Lower Respiratory Illness, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
Trial summary
At our field site in southern Nepal, acute respiratory illness (ARI) has been a leading cause of mortality among young children. Besides immunization there is little evidence for effective primary preventive approaches for ARI on a population basis. Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Lower Respiratory Illness
- What is being tested?
- Improved biomass cookstove with exterior ventilation and Phase 2 intervention arm (LPG stove)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,678 participants
- Where
- 1 siteNepal
- Study dates
- Aug 2009to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All households with traditional open burning cookstoves in the study area.
- households in the phase 1 study area that either participated in phase 1 or are newly eligible household since phase 1 began. Eligible households are those with either a resident married pregnant woman or at least one child less than 24 months of age.
Who cannot join
- Houses with walls of thatch or bamboo
- Phase 2
Trial locations and contacts
1 site in 1 country.
About this study
At our field site in southern Nepal, acute respiratory illness (ARI) has been a leading cause of mortality among young children. Besides immunization there is little evidence for effective primary preventive approaches for ARI on a population basis. Low birth weight is highly prevalent in this population as well affecting approximately 30% of live born infants. Low birth weight is a key determinant of neonatal mortality and has also been resistant to cost-effective interventions in resource poor settings. Given the lack of appropriate interventions for poor, rural areas in developing countries and the strong observational association between open burning of biomass fuel sources and ARI in young children and low birth weight, we have designed a community-based randomized trial to determine if reductions in household indoor smoke exposure can reduce the incidence and duration of acute lower respiratory infections in children <36 months of age and low birthweight among newborn infants. Household indoor smoke reduction will be accomplished by replacing the current cook stove in the household with a locally appropriate, inexpensive model that is more efficient and vented to the exterior. In addition, we will assess the impact on respiratory function and symptoms among adults in the household. The project has 2 phases. Phase 1 is a cluster-randomized, community-based, step-wedge trial of cookstove replacement in a rural population of southern Nepal. Households will be randomized to receive replacement of their cook stove with an appropriately designed, efficient stove that is vented to the exterior at different time periods during the course of the study. An initial period of surveillance for ARI and low birth weight will establish a baseline rate for all clusters. This will be followed by the randomized, serial replacements of cook stoves over a 12 month period. Surveillance will continue throughout this period and for an additional 6 -18 months depending on when the stove was replaced. Phase 2 is a individually randomized trial in a subset of households that will receive either the improved biomass stove from phase 1 or a LPG stove and gas. Follow-up for phase 2 will be for 12 months with the same outcomes as phase 1. Measurement of indoor air particulate concentration will be conducted in all households before and after stove replacement. The analysis for both phases will focus on estimating the impact on incidence of ARI in children and low birth weight among live births as a result of stove replacement. Approximately 4200 children 1-35 months of age will be required to observe a minimum 10% reduction in risk of ARI with 90% power in phase 1. Given the expected number of live births to occur in these clusters, we can detect a 50 gram difference in birthweight with over 90% power and a type I error of 5%. Phase 2 will have lower power (total of 1800 households).
Read the detailed description
See brief summary above
- Conditions
- Acute Lower Respiratory Illness
- Being tested
- Improved biomass cookstove with exterior ventilation, Phase 2 intervention arm (LPG stove)
- Keywords
- pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved biomass cookstove with exterior ventilationOther
Also called Envirofit model G3555.
Improved cookstove design installed in house that is higher efficiency and is vented to the exterior.
Phase 2 intervention arm (LPG stove)Other
LPG two burner stove with a 12 month supply of LP gas.
| Study group | Role | What they receive |
|---|---|---|
| Improved biomass cookstove with exterior ventilation | Experimental | In phase 1, installation of an improved cookstove with ventilation to exterior is the active arm.
In phase 2, this improved biomass cookstove is the control arm. Receives: Other: Improved biomass cookstove with exterior ventilation |
| Traditional cookstove | No intervention | In phase 1, the control arm is the traditional standard open burning cookstove in house. |
| Phase 2 invervention arm (LPG stove) | Experimental | In phase 2 of this project, households are individually randomized to either continuation of the improved biomass stove from phase 1, or a new LPG stove and gas for 12 months. Receives: Other: Phase 2 intervention arm (LPG stove) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute lower respiratory illness.
Measured: <36 months of age
Incidence of Low Birthweight
Measured: All live births
Secondary outcomes (1)
Incidence of pre-term birth
Measured: all live births
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startAug 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lower Respiratory IllnessStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4,678 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Nepal Nutrition Intervention Project Sarlahi, Thrasher Research Fund, Tribhuvan University, Nepal
- Responsible party
- Principal investigator, James M. Tielsch, Johns Hopkins Bloomberg School of Public Health
- Investigators
- James M Tielsch, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786877
- Sponsor's protocol ID
- IRB00000332
- Other IDs
- R01ES015558
- Status last verified
- Jan 2015
- First submitted
- 5 Nov 2008
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tielsch JM, Katz J, Zeger SL, Khatry SK, Shrestha L, Breysse P, Checkley W, Mullany LC, LeClerq SC. Designs of two randomized, community-based trials to assess the impact of alternative cookstove installation on respiratory illness among young children and reproductive outcomes in rural Nepal. BMC Public Health. 2014 Dec 15;14:1271. doi: 10.1186/1471-2458-14-1271.
PubMed 25511324
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal
- ClinicalTrials.gov ID
- NCT00786877
- Acronym / sponsor ID
- IRB00000332
- Conditions
- Acute Lower Respiratory Illness
- Keywords
- pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,678 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Nepal Nutrition Intervention Project Sarlahi, Thrasher Research Fund, Tribhuvan University, Nepal
- Study start
- Aug 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At our field site in southern Nepal, acute respiratory illness (ARI) has been a leading cause of mortality among young children. Besides immunization there is little evidence for effective primary preventive approaches for ARI on a population basis. Low birth weight is highly prevalent in this population as well affecting approximately 30% of live born infants. Low birth weight is a key determinant of neonatal mortality and has also been resistant to cost-effective interventions in resource poor settings. Given the lack of appropriate interventions for poor, rural areas in developing countries and the strong observational association between open burning of biomass fuel sources and ARI in young children and low birth weight, we have designed a community-based randomized trial to determine if reductions in household indoor smoke exposure can reduce the incidence and duration of acute lower respiratory infections in children <36 months of age and low birthweight among newborn infants. Household indoor smoke reduction will be accomplished by replacing the current cook stove in the household with a locally appropriate, inexpensive model that is more efficient and vented to the exterior. In addition, we will assess the impact on respiratory function and symptoms among adults in the household. The project has 2 phases. Phase 1 is a cluster-randomized, community-based, step-wedge trial of cookstove replacement in a rural population of southern Nepal. Households will be randomized to receive replacement of their cook stove with an appropriately designed, efficient stove that is vented to the exterior at different time periods during the course of the study. An initial period of surveillance for ARI and low birth weight will establish a baseline rate for all clusters. This will be followed by the randomized, serial replacements of cook stoves over a 12 month period. Surveillance will continue throughout this period and for an additional 6 -18 months depending on when the stove was replaced. Phase 2 is a individually randomized trial in a subset of households that will receive either the improved biomass stove from phase 1 or a LPG stove and gas. Follow-up for phase 2 will be for 12 months with the same outcomes as phase 1. Measurement of indoor air particulate concentration will be conducted in all households before and after stove replacement. The analysis for both phases will focus on estimating the impact on incidence of ARI in children and low birth weight among live births as a result of stove replacement. Approximately 4200 children 1-35 months of age will be required to observe a minimum 10% reduction in risk of ARI with 90% power in phase 1. Given the expected number of live births to occur in these clusters, we can detect a 50 gram difference in birthweight with over 90% power and a type I error of 5%. Phase 2 will have lower power (total of 1800 households).
Detailed description
See brief summary above
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Improved biomass cookstove with exterior ventilation | Experimental | Other: Improved biomass cookstove with exterior ventilationIn phase 1, installation of an improved cookstove with ventilation to exterior is the active arm. In phase 2, this improved biomass cookstove is the control arm. |
| Traditional cookstove | No intervention | –In phase 1, the control arm is the traditional standard open burning cookstove in house. |
| Phase 2 invervention arm (LPG stove) | Experimental | Other: Phase 2 intervention arm (LPG stove)In phase 2 of this project, households are individually randomized to either continuation of the improved biomass stove from phase 1, or a new LPG stove and gas for 12 months. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All households with traditional open burning cookstoves in the study area.
- households in the phase 1 study area that either participated in phase 1 or are newly eligible household since phase 1 began. Eligible households are those with either a resident married pregnant woman or at least one child less than 24 months of age.
Key exclusion criteria (2 listed)
- Houses with walls of thatch or bamboo
- Phase 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improved biomass cookstove with exterior ventilationAlso: Envirofit model G3555.Improved cookstove design installed in house that is higher efficiency and is vented to the exterior. | Other | Improved biomass cookstove with exterior ventilation |
| Phase 2 intervention arm (LPG stove)LPG two burner stove with a 12 month supply of LP gas. | Other | Phase 2 invervention arm (LPG stove) |
Primary outcome
Incidence of acute lower respiratory illness.
Time frame: <36 months of age
Incidence of Low Birthweight
Time frame: All live births
1 secondary outcome
Incidence of pre-term birth
Time frame: all live births
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Derived from this study: PubMed 25511324Tielsch JM, Katz J, Zeger SL, Khatry SK, Shrestha L, Breysse P, Checkley W, Mullany LC, LeClerq SC. Designs of two randomized, community-based trials to assess the impact of alternative cookstove installation on respiratory illness among young children and reproductive outcomes in rural Nepal. BMC Public Health. 2014 Dec 15;14:1271. doi: 10.1186/1471-2458-14-1271.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M Tielsch, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Improved biomass cookstove with exterior ventilation and Phase 2 intervention arm (LPG stove) in people with Acute Lower Respiratory Illness, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute lower respiratory illness. (time frame: <36 months of age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.