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NCT Number: NCT06926946

SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes

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.

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Key information

Conditions

Acute Renal Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neonatal Morbidity Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. jOhn's Medical college & Hospital

Bengaluru, Karnataka, 560034, India

Location contact

Saudamini Nesargi, Dr.

CONTACT

919243472262

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 28 weeks of gestation Invasively ventilated

Exclusion criteria

  • major anomalies

Treatment and study plan

Intervention Arm- Cerebral Oximetry + Treatment Guideline

Other

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

Other names: NIRS

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

saudamini Nesargi, Dr.

CONTACT

[email protected]

9243472262 ext. 91

Sponsors and collaborators

Lead sponsor

St. John's Research Institute

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study 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

Acronym: SBIIIvR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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