Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Establish the Incidence Rate of Abdominal and Cerebral Hyperoxemia and Hypoxemia Events in Neonates at Birth
- Sponsor
- Xijing Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Cerebral and abdominal NIRS in neonates
- Last Updated
- 8 years ago
Overview
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.
Investigators
Tian Li-1
Department of Anesthesiology and Perioperative Medicine
Xijing Hospital
Eligibility Criteria
Inclusion Criteria
- •Term infants (37-42 weeks of gestation)
- •Elective cesarean section after pregnancy
Exclusion Criteria
- •Thick hair that makes good measurements difficult/impossible
- •Obvious malformations or syndrome
- •Complications in relation to the cesarean section
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pulse oximetry in neonates(After birth in 20 min)