Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates

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

• Registration Number: NCT03149731
• Lead Sponsor: Xijing Hospital

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 Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study Start: 2017-05-08
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Study First Posted: 2017-05-11
• Last Update Posted: 2017-05-11
• Primary Completion: 2017-11-01
• Study Completion: 2018-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Term infants (37-42 weeks of gestation)
2. Elective cesarean section after pregnancy

Exclusion Criteria

1. Thick hair that makes good measurements difficult/impossible
2. Obvious malformations or syndrome
3. Complications in relation to the cesarean section

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebral and abdominal NIRS in neonates	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 Outcome Measures

Name	Time	Method
Pulse oximetry in neonates	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).

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China