Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

Masimo

Status: Completed

Conditions: Anemia

Treatments: Device: Investigational Rainbow SpHb sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03120702

CHOC0002

Details and patient eligibility

About

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

Enrollment: 128 patients

Sex: All

Ages: Under 16 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

Neonatal Test Subjects

Experimental group

Description:

All test subjects in this group are neonatal patients who will receive a investigational Rainbow SpHb sensor.

Treatment:

Device: Investigational Rainbow SpHb sensor