Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

N/ACompletedNCT03120702

Masimo Corporation128 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

128

Conditions

Anemia

Interventions

Investigational Rainbow SpHb sensorDEVICE

Investigational Rainbow SpHb sensor

Eligibility

Sex: ALLMax age: 16 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Orange County

Orange, California, United States

Outcomes

Primary Outcomes

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.

Time frame: duration of surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.