Establish the Incidence Rate of Abdominal and Cerebral Hyperoxemia and Hypoxemia Events in Neonates at Birth Clinical Trial
Official title:
Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates
| Verified date | May 2017 |
| Source | Xijing Hospital |
| Contact | Li Tian |
| Phone | +86 29 84775337 |
| tianli_fmmu[@]163.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | February 1, 2018 |
| Est. primary completion date | November 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Xijing Hospital | Xi'an | Shaanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Xijing Hospital |
China,
BOOST II United Kingdom Collaborative Group.; BOOST II Australia Collaborative Group.; BOOST II New Zealand Collaborative Group., Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, De — View Citation
Schmid MB, Hopfner RJ, Lenhof S, Hummler HD, Fuchs H. Cerebral oxygenation during intermittent hypoxemia and bradycardia in preterm infants. Neonatology. 2015;107(2):137-46. doi: 10.1159/000368294. Epub 2014 Dec 20. — View Citation
Spaeder MC, Klugman D, Skurow-Todd K, Glass P, Jonas RA, Donofrio MT. Perioperative Near-Infrared Spectroscopy Monitoring in Neonates With Congenital Heart Disease: Relationship of Cerebral Tissue Oxygenation Index Variability With Neurodevelopmental Outc — View Citation
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network., Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sánchez PJ, — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cerebral and abdominal NIRS in neonates | 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. | After birth in 20 min | |
| Secondary | Pulse oximetry in neonates | 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). | After birth in 20 min |