SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes
NCT ID: NCT06926946
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1000 participants
INTERVENTIONAL
2025-07-31
2027-09-15
Brief Summary
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As low blood pressure is a risk factor for the development of kidney injury, normalizing blood pressure may decrease the incidence of kidney injury in new-borns who are on ventilator.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention Arm- Cerebral Oximetry + Treatment Guideline
Neonates who are ventilated in the NICU, in addition to standard care, will be monitored by cerebral oximetry. If the value falls below a certain threshold, the treatment guideline will be followed and corrective interventions undertaken.
Intervention Arm- Cerebral Oximetry + Treatment Guideline
if the cerebral oximeter shows low values, a pre designed treatment guideline will be followed and corrective actions taken.
Control Arm- standard care
Neonates who are ventilated in the NICU will receive standard care only.
No interventions assigned to this group
Interventions
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Intervention Arm- Cerebral Oximetry + Treatment Guideline
if the cerebral oximeter shows low values, a pre designed treatment guideline will be followed and corrective actions taken.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
28 Days
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
St. John's Research Institute
OTHER
Responsible Party
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Locations
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St. jOhn's Medical college & Hospital
Bengaluru, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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Saudamini Nesargi, Dr.
Role: primary
Other Identifiers
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229/2024
Identifier Type: -
Identifier Source: org_study_id
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