Cerebral Saturation Monitoring for Brain Hypoxia in Premature Infants

(BOX Trial)

Overseen By Valerie Chock, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Congenital conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral saturations (Csat) using near-infrared spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring group with visible reading of Csat or to a control group with cerebral saturation monitoring, but with blinded Csat measures. Those in the targeted Csat group will follow a treatment guideline to maintain cerebral oxygenation in the target range. The primary outcome is neurodevelopmental outcome as determined by Bayley III cognitive scale score.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Clinical algorithm for monitoring brain hypoxia in premature infants?

Research shows that using cerebral near-infrared spectroscopy (NIRS) can help monitor brain oxygen levels in newborns, which is crucial for preventing brain damage due to low oxygen. This method has been effective in providing continuous and noninvasive monitoring, which is important for managing oxygen supply in premature infants. ^{1 2 3 4 5}

Is cerebral saturation monitoring safe for use in premature infants?

Cerebral saturation monitoring in preterm infants is generally considered safe, but there are potential risks such as skin breakdown and disturbance from additional equipment. The SafeBoosC project highlights the importance of minimizing disturbance unless necessary, and while cerebral oximeters are approved for clinical use, careful management is needed to avoid mismanagement of cerebral oxygenation. ^{6 7 8 9 10}

How does the treatment 'Clinical algorithm' for brain hypoxia in premature infants differ from other treatments?

The 'Clinical algorithm' treatment is unique because it involves continuous monitoring of cerebral oxygen levels using near-infrared spectroscopy (NIRS) and other non-invasive methods to adjust oxygen supply in real-time, aiming to prevent both low and high oxygen levels in the brain, which are harmful to premature infants. This approach is different from traditional methods that do not provide continuous, real-time data to guide oxygen therapy. ^{1 3 4 5 11}

Eligibility Criteria

This trial is for very preterm infants less than 6 hours old, born at least 23 but less than 29 weeks gestation. It's not suitable for babies with skin issues preventing NIRS sensor placement, life expectancy-affecting congenital conditions other than premature birth, or those not receiving full intensive care.

Inclusion Criteria

I am less than 6 hours old.

My baby was born between 23 and 29 weeks of pregnancy.

Exclusion Criteria

My skin cannot support the placement of NIRS sensors.

You have a condition that you were born with that could affect how long you live or how your brain develops.

I have chosen not to receive all possible intensive care treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants are monitored for cerebral saturations using NIRS, with targeted interventions for those in the targeted Csat group during the first week of life

1 week

Continuous monitoring

Follow-up

Participants are monitored for neurodevelopmental outcomes and other health indicators until hospital discharge

3 months

Long-term Follow-up

Neurodevelopmental outcomes assessed using Bayley Scales at 22-26 months of age

22-26 months

Treatment Details

Interventions

• Clinical algorithm

Trial Overview The study tests if setting target ranges for brain oxygen levels in extremely preterm infants improves their brain development outcomes by age 22-26 months. Infants are randomly assigned to either a group with visible cerebral oxygen readings or a control group with hidden readings.

Participant Groups

Group I: Non-targeted Csats Active Control 1 Intervention

Subjects randomized to the non-targeted Csat arm will have NIRS (near-infrared spectroscopy) monitoring of Csats, but Csat values will be obscured and not available to providers. These subjects will not have any algorithm-driven clinical interventions for Csat.

Group II: Targeted Csats Active Control 1 Intervention

Subjects randomized to the targeted Csat arm will have NIRS monitoring of cerebral saturations (Csat) and will have algorithm-driven clinical interventions to maintain Csat within target range in the first week of life.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Automated adjustment of inspired oxygen fraction (FiO2) significantly improved the time very low birth weight infants spent within the target arterial oxygen saturation (SpO2) range, increasing it from 69.1% to 76.3% compared to manual adjustments.

The use of automated FiO2 control also reduced the number of prolonged hypoxemic episodes (SpO2 <88%) significantly, but it did not have a notable impact on cerebral tissue oxygen saturation (SctO2).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of automated adjustment of the inspired oxygen on fluctuations of arterial and regional cerebral tissue oxygenation in preterm infants with frequent desaturations. Waitz, M., Schmid, MB., Fuchs, H., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Multi-Parametric Evaluation of Cerebral Hemodynamics in Neonatal Piglets Using Non-Contrast-Enhanced Magnetic Resonance Imaging Methods. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Role of Near-Infrared Spectroscopy in Monitoring the Clinical Course of Asphyxiated Neonates Treated with Hypothermia. [2022]

3. Austria pubmed.ncbi.nlm.nih.gov

Continuous quantitative monitoring of cerebral oxygen metabolism in neonates by ventilator-gated analysis of NIRS recordings. [2021]

4. Jamaica pubmed.ncbi.nlm.nih.gov

Comparison of Cerebral Oximeter and Pulse Oximeter Values in the First 72 Hours in Premature, Asphyctic and Healthy Newborns. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of automated adjustment of the inspired oxygen on fluctuations of arterial and regional cerebral tissue oxygenation in preterm infants with frequent desaturations. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Cerebrovascular reactivity to carbon dioxide tension in newborns: data from combined time-resolved near-infrared spectroscopy and diffuse correlation spectroscopy. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Regional tissue oxygenation in association with duration of hypoxaemia and haemodynamic variability in preterm neonates. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Automated oxygen control for very preterm infants and neurodevelopmental outcome at 2 years-a retrospective cohort study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Monitoring cerebral oxygenation of preterm infants using a neonatal specific sensor. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Cerebral Oximetry in Preterm Infants-To Use or Not to Use, That Is the Question. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Near-Infrared Spectroscopy Measured Cerebral Blood Flow from Spontaneous Oxygenation Changes in Neonatal Brain Injury. [2022]