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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01676610

Acronym

iPOP

Enrollment

3149

Registered

2012-08-31

Start date

2012-01-31

Completion date

2013-06-30

Last updated

2014-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia, Neonatal Sepsis, Pneumonia

Keywords

Pulse Oximetry, Pediatrics, Pakistan, Hypoxemia, Neonatal Sepsis, Pneumonia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 59 Days

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Prevalence of hypoxemia	Over the duration of hopsital stay, on average 24 hours

Secondary

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

Countries

Canada, Pakistan

Outcome results