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Clinical Trials/NCT03149731
NCT03149731
Unknown
Not Applicable

Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates

Xijing Hospital1 site in 1 country120 target enrollmentMay 8, 2017

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.

Registry
clinicaltrials.gov
Start Date
May 8, 2017
End Date
February 1, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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