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Completed

NCT Number: NCT01676610

Infant Pulse Oximetry in Pakistan Study

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Prevalence of hypoxemia

    Time frame: Over the duration of hopsital stay, on average 24 hours

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study 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

Acronym: iPOP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 31, 2012
Registry last updated
May 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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