NCT06926946

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: St. John's Research Institute · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Renal Failure
• Neonatal Morbidity

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-07-31
• Primary completion: 2027-06-01
• Completion: 2027-09-15
• First posted: 2025-04-15
• Last updated: 2025-07-23

Locations

1 site across 1 country: India