NCT03149731

Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Near-infrared spectroscopy (NIRS) functions in a manner similar to pulse oximetry, using the difference in absorptive qualities of oxy- and deoxyhemoglobin to infrared light to quantify the percent saturation. There is also available evidence shows that tissue oximetry is sensitive and has a quicker response to physiological derangement, such as bradycardia, in preterm newborns. Additionally, it is demonstrated that reduced postoperative cerebral tissue oxygenation index variability in neonatal survivors of congenital heart disease surgery with poor neurodevelopmental outcomes. The SafeBoosC phase II randomized clinical trial hypothesizes that the burden of hypo- and hyperoxia can be reduced, and consequently the risk of brain injury, by the combined use of close monitoring of the cerebral rStO2 and an evidence-based treatment guideline to correct deviations in rStO2 outside a predefined target range. In this study, we will monitor 2 different tissue beds including cerebral and abdominal somatic tissue rStO2 and SpO2 in neonates. Further research is needed to investigate clinical implications for using this measure to drive therapeutic interventions.

Conditions

• Establish the Incidence Rate of Abdominal and Cerebral Hyperoxemia and Hypoxemia Events in Neonates at Birth

Interventions

Type	Name	Description
DEVICE	NIRS	The recent technological advancement of tissue NIRS enables continuous, real time and bedside monitoring of hemoglobin oxygen saturation in mixed arterial, venous, and primarily capillary blood in the tissue bed being probed.

Timeline

• Start date: 2017-05-08
• Primary completion: 2017-11-01
• Completion: 2018-02-01
• First posted: 2017-05-11
• Last updated: 2017-05-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study