Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-23

Study Completion Date

2017-04-20

Brief Summary

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

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Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Neonatal Test Subjects

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

Group Type EXPERIMENTAL

Investigational Rainbow SpHb sensor

Intervention Type DEVICE

Investigational Rainbow SpHb sensor

Interventions

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Investigational Rainbow SpHb sensor

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes