SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes

Not Applicable

Not yet recruiting

• Conditions: Acute Renal Failure; Neonatal Morbidity

• Registration Number: NCT06926946
• Lead Sponsor: St. John's Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-11
• Last Update Submitted: 2025-04-11
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Study Start: 2025-05-29
• Primary Completion: 2027-06-01
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• > 28 weeks of gestation Invasively ventilated

Exclusion Criteria

• major anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
composite outcome of death and acute kidney injury	From randomization to discharge up to 2months of life	composite outcome of death and acute kidney injury

Trial Locations

Locations (1)

St. jOhn's Medical college & Hospital; 🇮🇳 Bengaluru, Karnataka, India