Study definitions and eligibility criteria
| Definitions | |
| Fast breathing for age | Children 2 to <12 months of age: RR ≥50 breaths per min Children ≥12 months of age: RR ≥40 breaths per min |
| Severe respiratory distress | Grunting, nasal flaring and/or head nodding |
| WHO IMCI general danger signs | Lethargy or unconsciousness, convulsions, vomiting everything, inability to drink or breastfeed |
| Eligibility criteria | |
| Inclusion criteria | Chest-indrawing pneumonia cohort 2 to 23 months of age Cough <14 days or difficulty breathing Visible indrawing of the chest wall with or without fast breathing for age Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return for a scheduled study follow-up visit No pneumonia cohort 2 to 23 months of age Cough <14 days or difficulty breathing Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return for a scheduled study follow-up visit |
| Exclusion criteria | Chest-indrawing pneumonia cohort Resolution of chest indrawing after bronchodilator challenge if wheezing at screening examination Severe respiratory distress Arterial SpO2 <90% in room air, as assessed noninvasively by a pulse oximeter WHO IMCI general danger signs Stridor when calm Known or possible tuberculosis (history of a cough ≥14 days) Any medical or psychosocial condition or circumstance that, in the opinion of the investigators, would interfere with the conduct of the study or for which study participation might jeopardise the child's health Living outside the study catchment area No pneumonia cohort Axillary temperature ≥38°C Fast breathing for age Visible indrawing of the chest wall SpO2 <95% in room air, as assessed noninvasively by a pulse oximeter WHO IMCI general danger signs Stridor when calm Known or possible tuberculosis (history of a cough ≥14 days) Any medical or psychosocial condition or circumstance that, in the opinion of the investigators, would interfere with the conduct of the study or for which study participation might jeopardise the child's health Living outside the study catchment area |
RR: respiratory rate; WHO: World Health Organization; IMCI: Integrated Management of Childhood Illnesses; SpO2: oxyhaemoglobin saturation.