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OpenTrials
Completed

NCT Number: NCT03120702

Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

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

Completed

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

Up to 16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Orange County

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigational Rainbow SpHb sensor

Device

Investigational Rainbow SpHb sensor

Primary outcomes

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

    Time frame: duration of surgery

    To study the SpHb sensor in neonatal population.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2017
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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