Neonatal Non-Invasive Hemoglobin Determination

Infant, Newborn Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01335919
• Other study ID #: 10-007757
• Status: Withdrawn
• Phase: N/A
• First received: February 2, 2011
• Last updated: January 7, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Masimo Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No