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

Brief Summary:
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.

Condition or disease
Hypoxemia Neonatal Sepsis Pneumonia

Study Type : Observational
Actual Enrollment : 3149 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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.

Primary Outcome Measures :
  1. Prevalence of hypoxemia [ Time Frame: Over the duration of hopsital stay, on average 24 hours ]

Secondary Outcome Measures :
  1. Validity of PO [ Time Frame: Baseline, +2 hours ]
    Validity of PO for the detection of infant illness, in comparison to physician assessment.

  2. Comparison of PO Measurements [ Time Frame: Baseline, +2 hours ]
    Between-devices comparison of PO measurements

  3. Operational Feasibility [ Time Frame: Baseline, +2 hours ]
    Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)

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Ages Eligible for Study:   up to 59 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Young infants, aged 0-59 days.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01676610

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Aga Khan University
Karachi, Pakistan
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Daniel Roth, MD The Hospital for Sick Children

Responsible Party: Daniel Roth, Staff Physician, Paediatric Medicine, The Hospital for Sick Children Identifier: NCT01676610     History of Changes
Other Study ID Numbers: 1000028096
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Daniel Roth, The Hospital for Sick Children:
Pulse Oximetry
Neonatal Sepsis

Additional relevant MeSH terms:
Neonatal Sepsis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Infant, Newborn, Diseases