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

St. John's Research Institute

Status: Not yet enrolling

Conditions: Neonatal Morbidity; Acute Renal Failure

Treatments: Other: Intervention Arm- Cerebral Oximetry + Treatment Guideline

Study type: Interventional

Funder types: Other

Identifiers

NCT06926946

229/2024

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 28 weeks of gestation Invasively ventilated

Exclusion criteria

• major anomalies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

Intervention Arm- Cerebral Oximetry + Treatment Guideline

Experimental group

Description:

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.

Treatment:

Other: Intervention Arm- Cerebral Oximetry + Treatment Guideline

Control Arm- standard care

No Intervention group

Description:

Neonates who are ventilated in the NICU will receive standard care only.