Randomised Exposure Study of Pollution Indoors and Respiratory Effects (RESPIRE): the effect of reducing exposure to smoke from traditional woodstoves on child pneumonia in rural Guatemala

Woodsmoke exposure and childhood acute lower respiratory infections in Guatemala: a randomised intervention

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29007942

Enrollment

500

Registered

2009-10-14

Start date

2002-10-19

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory tract infection (ARI) in children under 18 months Respiratory Acute upper respiratory infections of multiple and unspecified sites

Interventions

The intervention group was offered a chimney stove (plancha) at the beginning of the study. The improved chimney stove was locally made, well-liked by people in the community, and the stove of choice

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Households used only an open fire for cooking and heating 2. Had a pregnant woman or child less than 4 months residing in the home 3. Identified as Mam (the regional ethnic group) 4. Minimal summer migration (less than 12 weeks per year)

Exclusion criteria

Exclusion criteria: 1. The household is already using a chimney stove for cooking 2. There is no child less than 4 months of age or a pregnant woman residing in the home 3. Seasonal migration required the family to move to another region for more than 12 weeks of the year

Design outcomes

Primary

Measure	Time frame
Physician-diagnosed pneumonia in children through 18 months of age. Pneumonia case finding and management were based on the Integrated Management of Childhood Illness (IMCI) Strategy, developed by World Health Organization (WHO)/United Nations Children's Fund (UNICEF). This approach was selected because: 1. Experience has demonstrated that locally recruited field staff can be trained to assess ALRI and other common conditions using this method 2. In terms of case definition, it is sufficiently valid and consistent with most other recent population-based field studies of ALRI 3. There are well developed training materials and procedures for both case finding and management 4. It integrates case finding with clinically effective management of sick children Child health outcomes were assessed through weekly home visits by trained field workers, with referral to study physicians working in local community centres to maintain blindness to interventions status for clinical examination. Follow-up of children were from age at initial recruitment (birth to 4 months) until they reached 18 months of age. The fieldworkers, trained in IMCI, assessed and identified all children with rapid breathing, in addition to other signs of ALRI and the WHO-defined general danger signs. The rationale for carrying out the home visits at weekly intervals was based on the duration of pneumonia, in particular the duration of visible signs (principally fast breathing and chest indrawing). Estimates of this vary and depend on definitions of when an episode finishes. Weekly visits allowed almost all cases of ALRI to be identified through direct observation of the sick child, with a minority by mother's recall of the most relevant signs. Maternal recall of these signs does not have a high sensitivity and specificity, and was kept to a minimum. Children meeting criteria for possible ALRI (or other significant illness) were referred to one of the study doctors who carried out a clinical examination	—

Measure

Time frame

Physician-diagnosed pneumonia in children through 18 months of age. Pneumonia case finding and management were based on the Integrated Management of Childhood Illness (IMCI) Strategy, developed by World Health Organization (WHO)/United Nations Children's Fund (UNICEF). This approach was selected because: 1. Experience has demonstrated that locally recruited field staff can be trained to assess ALRI and other common conditions using this method 2. In terms of case definition, it is sufficiently valid and consistent with most other recent population-based field studies of ALRI 3. There are well developed training materials and procedures for both case finding and management 4. It integrates case finding with clinically effective management of sick children Child health outcomes were assessed through weekly home visits by trained field workers, with referral to study physicians working in local community centres to maintain blindness to interventions status for clinical examination. Follow-up of children were from age at initial recruitment (birth to 4 months) until they reached 18 months of age. The fieldworkers, trained in IMCI, assessed and identified all children with rapid breathing, in addition to other signs of ALRI and the WHO-defined general danger signs. The rationale for carrying out the home visits at weekly intervals was based on the duration of pneumonia, in particular the duration of visible signs (principally fast breathing and chest indrawing). Estimates of this vary and depend on definitions of when an episode finishes. Weekly visits allowed almost all cases of ALRI to be identified through direct observation of the sick child, with a minority by mother's recall of the most relevant signs. Maternal recall of these signs does not have a high sensitivity and specificity, and was kept to a minimum. Children meeting criteria for possible ALRI (or other significant illness) were referred to one of the study doctors who carried out a clinical examination

—

Secondary

Measure	Time frame
Derived from the case finding methods described above: 1. ARI outcomes based on field worker assessments in the home: 1.1. Acute upper respiratory infections 1.2. All ALRI 1.3. Severe ALRI 2. ARI outcomes based on physician diagnosis and investigations: 2.1. Severe (hypoxaemic) physician-diagnosed pneumonia 2.2. All RSV positive physician-diagnosed pneumonia 2.3. Severe (hypoxaemic) RSV positive physician-diagnosed pneumonia 2.4. All RSV negative physician-diagnosed pneumonia 2.5. Severe (hypoxaemic) RSV negative physician-diagnosed pneumonia 2.6. All chest X-ray positive physician-diagnosed pneumonia 2.7. Severe (hypoxaemic) chest X-ray positive physician-diagnosed pneumonia 3. Outcomes based on verbal autopsies: 3.1. All deaths 3.2. Deaths due to pneumonia 4. Other child health outcomes: 4.1. Diarrhoea 4.2. Birth weight 4.3. Burns and scalds	—

Measure

Time frame

Derived from the case finding methods described above: 1. ARI outcomes based on field worker assessments in the home: 1.1. Acute upper respiratory infections 1.2. All ALRI 1.3. Severe ALRI 2. ARI outcomes based on physician diagnosis and investigations: 2.1. Severe (hypoxaemic) physician-diagnosed pneumonia 2.2. All RSV positive physician-diagnosed pneumonia 2.3. Severe (hypoxaemic) RSV positive physician-diagnosed pneumonia 2.4. All RSV negative physician-diagnosed pneumonia 2.5. Severe (hypoxaemic) RSV negative physician-diagnosed pneumonia 2.6. All chest X-ray positive physician-diagnosed pneumonia 2.7. Severe (hypoxaemic) chest X-ray positive physician-diagnosed pneumonia 3. Outcomes based on verbal autopsies: 3.1. All deaths 3.2. Deaths due to pneumonia 4. Other child health outcomes: 4.1. Diarrhoea 4.2. Birth weight 4.3. Burns and scalds

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Countries

Guatemala

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026