SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes (SBIIIvR)

July 17, 2025 updated by: St. John's Research Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Karnataka
      • Bengaluru, Karnataka, India, 560034
        • St. John's Medical college & Hospital
        • Contact:
          • Saudamini Nesargi, Dr.
          • Phone Number: 919243472262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • > 28 weeks of gestation Invasively ventilated

Exclusion Criteria:

  • major anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • NIRS
No Intervention: Control Arm- standard care
Neonates who are ventilated in the NICU will receive standard care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite outcome of death and acute kidney injury
Time Frame: From randomization to discharge up to 2months of life
composite outcome of death and acute kidney injury
From randomization to discharge up to 2months of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. John's Research Institute

Collaborators

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 31, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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