Neonatal Non-Invasive Hemoglobin Determination
The purpose of this study is to evaluate hemoglobin (Hgb) measurement by Masimo-developed pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).
Infant, Low Birth Weight
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Non-invasive Continuous Hemoglobin in Pediatric Medicine: a Comparison Between Standard of Care CBC Hemoglobin (ADVIA 2120®) and the New Masimo® SpHb® Neonatal Sensor|
- Non-invasive, photoplethysmographic, hemoglobin reading (SpHb®) [ Time Frame: up to 5 minutes ] [ Designated as safety issue: No ]The primary endpoint is comparing at least one simultaneous non-invasive, photoplethysmographic, hemoglobin reading (SpHb®) and one invasive hemoglobin measurements (Hb) for each subject. (SpHb® vs. Hb)
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Subjects admitted for surgery or to the pediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) who require daily and/or multiple blood samples for hemoglobin measurement.
This collaborative study with Masimo Corporation will involve 2 phases. In the first phase of this study, 25 subjects weighing 0.5 to 3.0 kg will be recruited and hemoglobin values will be obtained from the non-invasive probe at the same time as blood samples are routinely drawn for Hgb analysis using the cyanomethemoglobin method (ADVIA 2121). Masimo Corporation will use this data to calibrate or modify the hemoglobin reading (SpHb®) sensors and monitors. All results and conclusions from this phase will be discussed with the investigation team in order to determine if additional subjects are needed (at increments of 25 subjects at a time). Once the sensor designs have been optimized, another group of patients will be studied to document the accuracy and precision of the hemoglobin reading (SpHb®) measurements.