SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorSt. John's Research Institute

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

> 28 weeks of gestation Invasively ventilated

Disqualifiers

major anomalies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention Arm- Cerebral Oximetry + Treatment Guideline

    Other intervention

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

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Intervention Arm- Cerebral Oximetry + Treatment GuidelineExperimental treatment 1 intervention
Group B: Control Arm- standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

composite outcome of death and acute kidney injury

composite outcome of death and acute kidney injury

Time frame
From randomization to discharge up to 2months of life

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. John's Research Institute

Lead sponsor

Rigshospitalet, Denmark

Collaborator

This trial is not recruiting at the moment. You can still explore other options: