Infant Pulse Oximetry in Pakistan Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypoxemia, Neonatal Sepsis, Pneumonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant presenting to the Bilal or Bhains PHC in Karachi, Pakistan Age 0 - 59 days Exclusion Criteria: Clinic visit is for scheduled injectable antibiotic administration (e.g., SAT trial)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 59 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants presenting to the Clinic<br>Infants presenting to the Bilal and Bhains Colony Health Center. Devices used to measure Pulse Oximetry (PO) include Rad-5v by Masimo, TuffSat by GE, N-65 by Nellcor, PRO2 by Conmed, and Lifebox by Acare. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hypoxemia |  | Over the duration of hopsital stay, on average 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of PO | Validity of PO for the detection of infant illness, in comparison to physician assessment. | Baseline, +2 hours | 
| Comparison of PO Measurements | Between-devices comparison of PO measurements | Baseline, +2 hours | 
| Operational Feasibility | Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices) | Baseline, +2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulse Oximetry, Pediatrics, Pakistan, Hypoxemia, Neonatal Sepsis, Pneumonia