Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03120702

Enrollment

128

Registered

2017-04-19

Start date

2013-07-23

Completion date

2017-04-20

Last updated

2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Brief summary

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

Interventions

DEVICEInvestigational Rainbow SpHb sensor

Investigational Rainbow SpHb sensor

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 16 Weeks

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026