Impact of Pulse Oximetry on Hospital Referral Acceptance in Children Under 5 With Severe Pneumonia in District Jamshoro - A Cluster Randomized Trial - (GAPPD Scale up Project)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aga Khan University
- Enrollment
- 543
- Locations
- 1
- Primary Endpoint
- Predictors of hospital referral acceptance
Study Overview
Brief Summary
The study assesses and compares the effect of 'pulse oximetry' (PO) used by Lady Health Workers (LHWs) at household level on increasing hospital referral acceptance rates in intervention clusters (district Jamshoro) for 0-59 months old children with severe pneumonia with the effect of LHWs using clinical signs alone in non-intervention clusters of the same district.
Detailed Description
Pneumonia accounts for an estimated 18% of under-5 mortality across the globe. Majority of these pneumonia-specific deaths occur in 15 countries, in which Pakistan ranks fifth. Failure to seek early care and delays in hospital referral are commonly acknowledged determinants of mortality in childhood pneumonia with a higher proportion reported from rural settings than urban. Acceptance rates of 'facilitated' hospital referral advice have been reported as low as 8-23% for sick young infants in peri-urban Karachi. They are even lower for non-facilitated referral in rural settings in children under five with severe pneumonia in rural settings.
Hypoxemia is an important sign of cardio-respiratory compromise in acutely ill children with a reported prevalence of 5.9%-58.9% in children aged 0-59 months from facilities and 16.1%-38.7% from community settings. Pulse oximetry (PO) is a rapid, portable, non-invasive, and accurate method of measuring arterial hemoglobin oxygenation (Sp02), and has therefore been used in the trial and clinical settings to detect hypoxemia. According to literature, mortality increases 4.3 times in children with pneumonia and hypoxemia than in those without hypoxemia.
The study hypothesizes that hypoxemia is a valuable sign of severe and very severe pneumonia in children 0-59 months and early identification at the community level followed by appropriate management with supplemental oxygen and antibiotics at the facility will improve acceptance of hospital referral and clinical outcomes
Study aims and design:
The overall aim of the study is to assess if detection of hypoxemia and/or severe pneumonia in children 0-59 months by LHWs during their monthly home visits will increase hospital referral acceptance among families in District Jamshoro, Sindh, Pakistan.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 0 Months to 59 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children of 0-59 months age
- •Signs of severe pneumonia (clinical signs only in control clusters, clinical signs and/or hypoxemia in intervention clusters)
- •Written informed consent by legal guardian
Exclusion Criteria
- •1. Residents of out of catchment areas
Arms & Interventions
Intervention Cluster
Signs and symptoms of severe pneumonia Pulse Oximetry
Intervention: Pulse Oximetry (Device)
Non-Intervention Cluster
Signs and symptoms of severe pneumonia
Outcomes
Primary Outcomes
Predictors of hospital referral acceptance
Time Frame: Day 0-3
number of children having the predictors (severe signs and symptoms, low distance from referral facility and high WAMI score)
Hospital Referral Acceptance
Time Frame: Day 3 to 7
Number of children accepting hospital referral out of total severe pneumonia identified
Secondary Outcomes
- Comparison of clinical outcomes of children 0-59 months who accepted referral to those who refused admission and were treated at home(Day 3 to Day 7)
Investigators
Dr Fatime Mir
Associate Professor
Aga Khan University
