Clinical Trial: Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates

Brief 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.

Detailed Summary:
Sponsor: Xijing Hospital

Current Primary Outcome: Cerebral and abdominal NIRS in neonates [ Time Frame: After birth in 20 min ]

Cerebral and abdominal tissue oxygen saturation was obtained using 4-wavelength (690, 780, 805 and 850nm) near-infrared spectroscopy (FORE-SIGHT, CAS Medical Systems, Branford, CT) with a transducer containing a fiber optic emitter and one detector located 25mm from the light source. A non-adhesive optode (FORE-SIGHT sensor kit small, CAS Medical Systems, Branford, CT) was placed on the left forehead and abdomen.


Original Primary Outcome: Same as current

Current Secondary Outcome: Pulse oximetry in neonates [ Time Frame: After birth in 20 min ]

Pulse oximetry data (SpO2) were collected in a time-synchronized fashion with the NIRS data using the transport monitor (Philips IntelliVue MMS X2 equipped with multi-measurement module, Philips Healthcare, Andover, MA) and a non-adhesive probe placed on the hand or foot (Neonatal-Adult SpO2 Sensor, Philips Healthcare, Andover, MA).


Original Secondary Outcome: Same as current

Information By: Xijing Hospital

Dates:
Date Received: May 8, 2017
Date Started: May 8, 2017
Date Completion: February 1, 2018
Last Updated: May 8, 2017
Last Verified: May 2017