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Neonatal Non-Invasive Hemoglobin Determination

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ClinicalTrials.gov Identifier: NCT01335919
Recruitment Status : Withdrawn (Company is redesigning measuring tool.)
First Posted : April 15, 2011
Last Update Posted : January 8, 2013
Masimo Corporation
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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).

Condition or disease
Surgical Procedures Infant, Newborn Infant, Low Birth Weight

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
Actual Enrollment : 0 participants
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
Study Start Date : September 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

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.

Primary Outcome Measures :
  1. Non-invasive, photoplethysmographic, hemoglobin reading (SpHb®) [ Time Frame: 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)

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Neonates admitted for a surgical procedure or admitted to the PICU or NICU where hemoglobin determinations are expected.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335919

Sponsors and Collaborators
Children's Hospital of Philadelphia
Masimo Corporation
Principal Investigator: Denis Jablonka, MD Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01335919     History of Changes
Other Study ID Numbers: 10-007757
First Posted: April 15, 2011    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Children's Hospital of Philadelphia:
Monitoring, Physiologic
Blood Gas Monitoring, Transcutaneous

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms