Taneja 2017.

Study name	Enhanced community case management to increase access to pneumonia treatment
Methods	Cluster‐randomized controlled trial
Participants	Infants aged 7–59 days with fast breathing and children aged 2–59 months with chest indrawing pneumonia without hypoxaemia Exclusion criteria: non‐consent, danger signs, hypoxaemia
Interventions	Enhanced iCCM for diarrhoea and pneumonia, with the addition of pulse oximetry by LHWs (ASHA) for the latter Quote: "The study is a cluster randomized open label non inferiority trial where subcentres will be randomized into intervention and control. Infants aged 7–59 days with fast breathing and absence of danger signs and hypoxaemia and children aged 2–59 months with chest indrawing and absence of danger signs and hypoxaemia will be treated with amoxicillin by ASHAs in the intervention clusters and referred to health facilities in the control cluster. Cases identified by ASHAs will be assessed and all enrolled children will be followed up on days 1, 2, 4 and 7. An independent team will assess outcomes on days 6 and 14 post identification of case. Acceptability and feasibility of using pulse oximetry will be examined."
Outcomes	Primary outcomes Death between day 1 and day 14 of enrolment Persistence of fast breathing in infants aged 7–59 days or persistence of chest indrawing in children aged 2–59 months at day 6 of enrolment Child hospitalized for any reason or has any indication of hospitalizations at day 6 of enrolment Development of serious adverse effect during the treatment period Secondary outcomes Evaluating the accuracy of pulse oximetry used by ASHA against standardized measurement by a trained supervisor Evaluating the impact of use of pulse oximetry on referral and treatment outcomes
Starting date	1 February 2017; end date 31 July 2018
Contact information	Dr Sunita Taneja; sunita.taneja@sas.org.in
Notes	Objective: to assess the effect of enhanced iCCM for diarrhoea and pneumonia treatment on mortality, treatment outcomes, accuracy of pulse oximetry used by ASHA and referral and treatment outcomes Location: India (subnational location not specified) Comparison: usual health services without enhanced iCCM Funding: WHO, Geneva