NCT06926946

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Jul 2025Sep 2027

First Submitted

Initial submission to the registry

April 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

April 2, 2025

Last Update Submit

July 17, 2025

Conditions

Acute Renal FailureNeonatal Morbidity

Keywords

Cerebral oximetryNIRSNeonateVentilatedKidney injury

Outcome Measures

Primary Outcomes (1)

  • composite outcome of death and acute kidney injury

    composite outcome of death and acute kidney injury

    From randomization to discharge up to 2months of life

Study Arms (2)

Intervention Arm- Cerebral Oximetry + Treatment Guideline

EXPERIMENTAL

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.

Other: Intervention Arm- Cerebral Oximetry + Treatment Guideline

Control Arm- standard care

NO INTERVENTION

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

Interventions

Intervention Arm- Cerebral Oximetry + Treatment GuidelineOTHER

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

Also known as: NIRS
Intervention Arm- Cerebral Oximetry + Treatment Guideline

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \> 28 weeks of gestation Invasively ventilated

You may not qualify if:

  • major anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. jOhn's Medical college & Hospital

Bengaluru, Karnataka, 560034, India

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

saudamini Nesargi, Dr.

CONTACT

9243472262saudamini_nesargi@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2025

First Posted

April 15, 2025

Study Start

July 31, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 15, 2027

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)