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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01335919

Enrollment

Registered

2011-04-15

Start date

2011-09-30

Completion date

2012-12-31

Last updated

2013-01-08

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

Conditions

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

Keywords

Hemoglobin, Monitoring, Physiologic, Blood Gas Monitoring, Transcutaneous

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results