Status:
COMPLETED
Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
NHS Lothian
Conditions:
Premature
Premature Infant
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and th...
Detailed Description
Presently oxygen is titrated against saturation (SpO2) by manual adjustment. Automated or servo-control systems have been developed that result in tighter control of SpO2 and more time spent in the in...
Eligibility Criteria
Inclusion
- Infants born at less than 30 weeks gestation
- Infants greater than 48 hours of age
- Infants who are receiving supplementary oxygen
- Person with parental responsibility able to give consent
Exclusion
- Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects)
- Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support)
- Parent/person with parental responsibility unable to give informed consent on behalf of the infant
- Infants born less than 22 weeks gestation
Key Trial Info
Start Date :
November 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04866342
Start Date
November 27 2020
End Date
August 28 2023
Last Update
September 25 2024
Active Locations (1)
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1
The Simpson Centre for Reproductive Health, Royal Infirmary Edinburgh
Edinburgh, City Of Edinburgh, United Kingdom, EH16 4SA