AnemiaNCT03120702
Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
A study testing Investigational Rainbow SpHb sensor in people with Anemia, run by Masimo Corporation at 1 site in United States.
Trial summary
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants Read more about this study
- Who is it for?
- Ages Up to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Investigational Rainbow SpHb sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2013to 20 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Orange County
Orange, California, 92868
About this study
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
- Conditions
- Anemia
- Being tested
- Investigational Rainbow SpHb sensor
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Rainbow SpHb sensorDevice
Investigational Rainbow SpHb sensor
| Study group | Role | What they receive |
|---|---|---|
| Neonatal Test Subjects | Experimental | All test subjects in this group are neonatal patients who will receive a investigational Rainbow SpHb sensor. Receives: Device: Investigational Rainbow SpHb sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start23 Jul 2013
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120702
- Sponsor's protocol ID
- CHOC0002
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population
- ClinicalTrials.gov ID
- NCT03120702
- Acronym / sponsor ID
- CHOC0002
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2013 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal Test Subjects | Experimental | Device: Investigational Rainbow SpHb sensorAll test subjects in this group are neonatal patients who will receive a investigational Rainbow SpHb sensor. |
Who may qualify
- Ages
- Up to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Rainbow SpHb sensorInvestigational Rainbow SpHb sensor | Device | Neonatal Test Subjects |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Rainbow SpHb sensor in people with Anemia, run by Masimo Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants (time frame: duration of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.