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Infant Pulse Oximetry in Pakistan Study (iPOP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01676610
First received: August 22, 2012
Last updated: August 30, 2012
Last verified: August 2012
History of Changes

August 22, 2012
August 30, 2012
January 2012
August 2012   (final data collection date for primary outcome measure)
Prevalence of hypoxemia [ Time Frame: Over the duration of hopsital stay, on average 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01676610 on ClinicalTrials.gov Archive Site
  • Validity of PO [ Time Frame: Baseline, +2 hours ] [ Designated as safety issue: No ]
    Validity of PO for the detection of infant illness, in comparison to physician assessment.
  • Comparison of PO Measurements [ Time Frame: Baseline, +2 hours ] [ Designated as safety issue: No ]
    Between-devices comparison of PO measurements
  • Operational Feasibility [ Time Frame: Baseline, +2 hours ] [ Designated as safety issue: No ]
    Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Young infants, aged 0-59 days.
  • Hypoxemia
  • Neonatal Sepsis
  • Pneumonia
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1400
October 2012
August 2012   (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)
Both
up to 59 Days
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Pakistan
 
NCT01676610
1000028096
No
The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Daniel Roth, MD The Hospital for Sick Children
The Hospital for Sick Children
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP