Infant Pulse Oximetry in Pakistan Study

Pneumonia Clinical Trial

— iPOP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676610
• Other study ID #: 1000028096
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: May 21, 2014
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3149
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 59 Days

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoxemia
• Neonatal Sepsis
• Pneumonia

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
Pakistan	Aga Khan University	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Countries where clinical trial is conducted

Canada,  Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of hypoxemia		Over the duration of hopsital stay, on average 24 hours	No
Secondary	Validity of PO	Validity of PO for the detection of infant illness, in comparison to physician assessment.	Baseline, +2 hours	No
Secondary	Comparison of PO Measurements	Between-devices comparison of PO measurements	Baseline, +2 hours	No
Secondary	Operational Feasibility	Operational feasibility (time to obtain measurement, acceptance by caregivers, robustness of devices)	Baseline, +2 hours	No