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NCT03120702 Clinical Trial

Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

Anemia Clinical Trial

Official title:
Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03120702
Other study ID # CHOC0002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 23, 2013
Est. completion date April 20, 2017

Study information
Verified date April 2021
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date April 20, 2017
Est. primary completion date April 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 16 Weeks
Eligibility Inclusion Criteria: - Male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care. - Ages: Newborn infants less than 16 weeks postnatal age. - Weight: Range from 500 g to 10 kg. - Able to obtain written informed consent from parents or legal guardians Exclusion Criteria: - Neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Investigational Rainbow SpHb sensor
Investigational Rainbow SpHb sensor

Locations
Country Name City State
United States Children's Hospital of Orange County Orange California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants To study the SpHb sensor in neonatal population. duration of surgery
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