Neonatal Non-Invasive Hemoglobin Determination

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Infant, Low Birth Weight; Infant, Newborn; Surgical Procedures

Detailed Description

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Neonates admitted for a surgical procedure or admitted to the PICU or NICU where hemoglobin determinations are expected.

Description

Inclusion Criteria:

1. Males or females weighing 0.5 kg to 3 kg.
2. 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.
3. Parental/guardian permission (informed consent)

Exclusion Criteria:

1. Subjects where blood samples are obtained through access types other than venous or arterial (e.g: intraosseous).
2. Subject weighing more than 3 kg.
3. Subjects who are too small or with any anatomical limitations that would preclude proper attachment of the adhesive sensor.
4. Any skin rash on the intended site of measurement. Severe allergy to adhesive tapes.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Neonate; 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?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Masimo Corporation
• Investigators: Principal Investigator: Denis Jablonka, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2012
• Study Completion (ANTICIPATED): December 1, 2012

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (ESTIMATE): April 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Hemoglobin; Monitoring, Physiologic; Blood Gas Monitoring, Transcutaneous
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 10-007757