Infant Pulse Oximetry in Pakistan Study (iPOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01676610
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : May 23, 2014
Information provided by (Responsible Party):
Daniel Roth, The Hospital for Sick Children

August 22, 2012
August 31, 2012
May 23, 2014
January 2012
June 2013   (Final data collection date for primary outcome measure)
Prevalence of hypoxemia [ Time Frame: Over the duration of hopsital stay, on average 24 hours ]
Same as current
Complete list of historical versions of study NCT01676610 on Archive Site
  • Validity of PO [ Time Frame: Baseline, +2 hours ]
    Validity of PO for the detection of infant illness, in comparison to physician assessment.
  • Comparison of PO Measurements [ Time Frame: Baseline, +2 hours ]
    Between-devices comparison of PO measurements
  • Operational Feasibility [ Time Frame: Baseline, +2 hours ]
    Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)
Same as current
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Infant Pulse Oximetry in Pakistan Study
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
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Young infants, aged 0-59 days.
  • Hypoxemia
  • Neonatal Sepsis
  • Pneumonia
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Infants presenting to the Clinic
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.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
June 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
up to 59 Days   (Child)
Contact information is only displayed when the study is recruiting subjects
Canada,   Pakistan
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Daniel Roth, The Hospital for Sick Children
The Hospital for Sick Children
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Principal Investigator: Daniel Roth, MD The Hospital for Sick Children
The Hospital for Sick Children
May 2014