Neonatal Non-Invasive Hemoglobin Determination

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Non-invasive Continuous Hemoglobin in Pediatric Medicine: a Comparison Between Standard of Care CBC Hemoglobin (ADVIA 2120®) and the New Masimo® SpHb® Neonatal Sensor

Conditions
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Surgical Procedures, Infant, Newborn, Infant, Low Birth Weight

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females weighing 0.5 kg to 3 kg. Neonates and infants and children admitted to the Children's Hospital of Philadelphia (CHOP)operating room (OR), PICU and NICU where hemoglobin measurements are anticipated. Parental/guardian permission (informed consent) Exclusion Criteria: Subjects where blood samples are obtained through access types other than venous or arterial (e.g: intraosseous). Subject weighing more than 3 kg. Subjects who are too small or with any anatomical limitations that would preclude proper attachment of the adhesive sensor. Any skin rash on the intended site of measurement. Severe allergy to adhesive tapes.

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonate<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-invasive, photoplethysmographic, hemoglobin reading (SpHb®) | 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) | up to 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemoglobin, Monitoring, Physiologic, Blood Gas Monitoring, Transcutaneous