Infant Pulse Oximetry in Pakistan Study

Completed

• Conditions: Neonatal Sepsis; Hypoxemia; Pneumonia

• Registration Number: NCT01676610
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-08-31
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3149

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of hypoxemia	Over the duration of hopsital stay, on average 24 hours

Secondary Outcome Measures

Name	Time	Method
Validity of PO	Baseline, +2 hours	Validity of PO for the detection of infant illness, in comparison to physician assessment.
Operational Feasibility	Baseline, +2 hours	Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)
Comparison of PO Measurements	Baseline, +2 hours	Between-devices comparison of PO measurements

Trial Locations

Locations (2)

Aga Khan University; 🇵🇰 Karachi, Pakistan

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada