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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Nepal1 site
  • Nepal Nutrition Intervention Project Sarlahi

    Kathmandu

Other trials in Nepal

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

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 groups in NCT00786877
Study groupRoleWhat they receive
Improved biomass cookstove with exterior ventilationExperimentalIn 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 cookstoveNo interventionIn phase 1, the control arm is the traditional standard open burning cookstove in house.
Phase 2 invervention arm (LPG stove)ExperimentalIn 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.

  1. Incidence of acute lower respiratory illness.

    Measured: <36 months of age

  2. Incidence of Low Birthweight

    Measured: All live births

Secondary outcomes (1)
  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.

  1. First posted6 Nov 2008 (estimated)
  2. Study startAug 2009
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

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)
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

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.

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