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临床试验/NCT01676610
NCT01676610已完成不适用

Infant Pulse Oximetry in Pakistan (iPOP) Study: Utility and Feasibility of Integrating Pulse Oximetry Into the Routine Assessment of Young Infants at First-level Clinics in Karachi, Pakistan

The Hospital for Sick Children2 个研究点 分布在 2 个国家目标入组 3,149 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,149
试验地点
2
主要终点
Prevalence of hypoxemia

研究概览

简要总结

Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid, portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting. In this research study, we propose to test the hypothesis that the use of pulse oximetry to detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible for the identification of the infants most urgently in need of medical care. We will enroll 1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi. Infants will undergo brief clinical assessment by a community health worker (CHW) based on the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm, assessment by two pulse oximetry devices, and examination by a physician. The primary outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain measurement, number of infants for who repeat measurements are required), and concordance between paired measurements on separate devices.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 59 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infant presenting to the Bilal or Bhains PHC in Karachi, Pakistan
  • Age 0 - 59 days

排除标准

  • Clinic visit is for scheduled injectable antibiotic administration (e.g., SAT trial)

结局指标

主要结局

Prevalence of hypoxemia

时间窗: Over the duration of hopsital stay, on average 24 hours

次要结局

  • Validity of PO(Baseline, +2 hours)
  • Operational Feasibility(Baseline, +2 hours)
  • Comparison of PO Measurements(Baseline, +2 hours)

研究者

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

Daniel Roth

Staff Physician, Paediatric Medicine

The Hospital for Sick Children

研究点 (2)

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