An observational study in Hypoxemia, Neonatal Sepsis and Pneumonia, sponsored by The Hospital for Sick Children. Completed at 2 sites in 2 countries. Open to participants aged 1 Day to 59 Days. Per ClinicalTrials.gov, last updated 2014-05-23.
Sponsored by The Hospital for Sick Children · Observational
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.
2,045 studies on the registry are indexed under Pneumonia; 284 are open to participants now.
This study's enrollment of 3,149 is above the median of 201 across 689 observational studies indexed under Pneumonia.
Browse Pneumonia studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Young infants, aged 0-59 days.
Exclusion Criteria:
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.
Prevalence of hypoxemia
Time frame: Over the duration of hopsital stay, on average 24 hours
Validity of PO
Validity of PO for the detection of infant illness, in comparison to physician assessment.
Time frame: Baseline, +2 hours
Comparison of PO Measurements
Between-devices comparison of PO measurements
Time frame: Baseline, +2 hours
Operational Feasibility
Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)
Time frame: Baseline, +2 hours
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children