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Not yet recruiting NCT06926946

SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes

No phase Interventional Acute Renal Failure Neonatal Morbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention Arm- Cerebral Oximetry + Treatment Guideline.
Who it may be relevant to
Registry conditions: Acute Renal Failure, Neonatal Morbidity. Basic parameters: 1 Day — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.

Primary outcome measures

  • composite outcome of death and acute kidney injury [Time frame: From randomization to discharge up to 2months of life]

Eligibility criteria

Inclusion criteria

  • > 28 weeks of gestation Invasively ventilated

Exclusion criteria

  • major anomalies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

India · 1 center
  • St. jOhn's Medical college & Hospital — Bengaluru

Identifiers

NCT: NCT06926946 · 229/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗