SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes

NCT ID: NCT06926946

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2027-09-15

Brief Summary

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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

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Conditions

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Acute Renal Failure Neonatal Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention Arm- Cerebral Oximetry + Treatment Guideline

Intervention Type OTHER

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

Control Arm- standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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NIRS

Eligibility Criteria

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Inclusion Criteria

* \> 28 weeks of gestation Invasively ventilated

Exclusion Criteria

* major anomalies
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

St. John's Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. jOhn's Medical college & Hospital

Bengaluru, Karnataka, India

Site Status

Countries

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India

Central Contacts

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saudamini Nesargi, Dr.

Role: CONTACT

9243472262 ext. 91

Facility Contacts

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Saudamini Nesargi, Dr.

Role: primary

919243472262

Other Identifiers

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229/2024

Identifier Type: -

Identifier Source: org_study_id

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