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临床试验/NCT03588377
NCT03588377已完成不适用

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)

Aga Khan University2 个研究点 分布在 1 个国家目标入组 543 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
543
试验地点
2
主要终点
Predictors of hospital referral acceptance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
0 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Residents of out of catchment areas

结局指标

主要结局

Predictors of hospital referral acceptance

时间窗: 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

时间窗: Day 3 to 7

Number of children accepting hospital referral out of total severe pneumonia identified

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Fatime Mir

Associate Professor

Aga Khan University

研究点 (2)

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