Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
1 other identifier
interventional
128
1 country
1
Brief Summary
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2013
CompletedFirst Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedApril 28, 2021
April 1, 2021
3.7 years
April 14, 2017
April 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
duration of surgery
Study Arms (1)
Neonatal Test Subjects
EXPERIMENTALAll test subjects in this group are neonatal patients who will receive a investigational Rainbow SpHb sensor.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Orange County
Orange, California, 92868, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 19, 2017
Study Start
July 23, 2013
Primary Completion
April 20, 2017
Study Completion
April 20, 2017
Last Updated
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share