Infant Pulse Oximetry in Pakistan Study (iPOP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Roth, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01676610
First received: August 22, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
Hypoxemia
Neonatal Sepsis
Pneumonia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Prevalence of hypoxemia [ Time Frame: Over the duration of hopsital stay, on average 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)


Enrollment: 3149
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   up to 59 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Young infants, aged 0-59 days.

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01676610

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

No publications provided

Responsible Party: Daniel Roth, Staff Physician, Paediatric Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01676610     History of Changes
Other Study ID Numbers: 1000028096
Study First Received: August 22, 2012
Last Updated: May 21, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Pulse Oximetry
Pediatrics
Pakistan
Hypoxemia
Neonatal Sepsis
Pneumonia

Additional relevant MeSH terms:
Pneumonia
Sepsis
Anoxia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014