Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates

NCT03149731 | Unknown DMC FDA Device

• 1 other identifier: XijingHosp
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pulse oximetry in neonates

  After birth in 20 min

Interventions

NIRS DEVICE

The recent technological advancement of tissue NIRS enables continuous, real time and bedside monitoring of hemoglobin oxygen saturation in mixed arterial, venous, and primarily capillary blood in the tissue bed being probed.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

120 ASA class I or II parturients between 37 to 42 weeks of gestation with singleton vertex pregnancy and scheduled for elective cesarean delivery under spinal anesthesia.

You may qualify if:

• Term infants (37-42 weeks of gestation)
• Elective cesarean section after pregnancy

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 029, China

RECRUITING

Related Publications (4)

• 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, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.

  PMID: 20472937 RESULT

• 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, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P. Oxygen saturation and outcomes in preterm infants. N Engl J Med. 2013 May 30;368(22):2094-104. doi: 10.1056/NEJMoa1302298. Epub 2013 May 5.

  PMID: 23642047 RESULT

• 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 Outcome. Pediatr Crit Care Med. 2017 Mar;18(3):213-218. doi: 10.1097/PCC.0000000000001056.

  PMID: 28067688 RESULT

• 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.

  PMID: 25531368 RESULT

Study Officials

• Li Tian

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Tian

CONTACT

+86 29 84775337; tianli_fmmu@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 11, 2017
• Study Start: May 8, 2017
• Primary Completion: November 1, 2017
• Study Completion: February 1, 2018
• Last Updated: May 11, 2017

Record last verified: 2017-05

Locations

CN (1)