Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
Not Applicable
Completed
- Conditions
- Anemia
- Interventions
- Device: Investigational Rainbow SpHb sensor
- Registration Number
- NCT03120702
- Lead Sponsor
- Masimo Corporation
- Brief Summary
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neonatal Test Subjects Investigational Rainbow SpHb sensor All test subjects in this group are neonatal patients who will receive a investigational Rainbow SpHb sensor.
- Primary Outcome Measures
Name Time Method Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants duration of surgery To study the SpHb sensor in neonatal population.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital of Orange County
🇺🇸Orange, California, United States