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SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes

The Effects of Treatment Guided by Cerebral Oximetry Monitoring on Renal Outcomes in Invasively Mechanically Ventilated Neonates: an Ancillary Study of the SafeBoosC-IIIv Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06926946
Acronym
SBIIIvR
Enrollment
1000
Registered
2025-04-15
Start date
2025-07-31
Completion date
2027-09-15
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Neonatal Morbidity

Keywords

Cerebral oximetry, NIRS, Neonate, Ventilated, Kidney injury

Brief summary

Cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the SafeBoosC treatment guideline. The guideline's interventions aims to stabilize blood pressure and oxygen levels. 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.

Interventions

OTHERIntervention Arm- Cerebral Oximetry + Treatment Guideline

if the cerebral oximeter shows low values, a pre designed treatment guideline will be followed and corrective actions taken.

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
St. John's Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

* \> 28 weeks of gestation Invasively ventilated

Exclusion criteria

* major anomalies

Design outcomes

Primary

MeasureTime frameDescription
composite outcome of death and acute kidney injuryFrom randomization to discharge up to 2months of lifecomposite outcome of death and acute kidney injury

Countries

India

Contacts

Primary Contactsaudamini Nesargi, Dr.
saudamini_nesargi@yahoo.com9243472262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026