Congenital DisordersNCT05673499
International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
An observational study of Congenital Disorders and Cerebral Desaturation, run by Children's Hospital of Philadelphia at 15 sites in 7 countries.
Trial summary
The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are: 1. The perioperative factors associated with occurrence of cerebral desaturation 2. Read more about this study
- Who is it for?
- Ages Up to 60 weeks
- Conditions the study is for
- Congenital Disorders, Cerebral Desaturation, Neonatal Surgery
- What is being tested?
- NIRS/EEG monitoring
- Type of treatment
- Medical device
- How many people
- 900 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 12 Aug 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 weeks
- All sexes
- Child
Study population: Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformat
Who may be able to join
- Infants ≤ 60 weeks post-menstrual age on day of surgery.
- Neonatal surgery for congenital abdominal/gastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid/pulmonary airway malformation (CCAM/CPAM), esophageal/tracheoesophageal fistula (EF/TEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma).
- The same patient may be enrolled multiple times for repeat or different procedures that meet the above criteria. These subjects will be counted more than once towards the enrollment goal.
- Parental/guardian permission.
Who cannot join
- 1) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.
Trial locations and contacts
15 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 7 countries
United States4 sites, 4 recruiting
- Not yet recruiting
Children's Medical Center Dallas
Dallas, Texas, 75235
Ethan Sanford, 303-520-8967, Ethan.Sanford@UTSouthwestern.edu
- Not yet recruiting
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Maria Matuszczak, 713-498-2768, maria.matuszczak@uth.tmc.edu
- Not yet recruiting
Children's Hospital at Montefiore/Albert Einstein College of Medicine
New York, New York, 10467
Jerry Chao, 917-860-5674, JECHAO@montefiore.org
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Charles Dean Kurth, MD, 215-590-1866, KURTHCD@chop.edu
China4 sites, 4 recruiting
- Not yet recruiting
Guangzhou women and children's medical center
Guangzhou
Xingrong Song, 8613922416303, sxjess@126.com
- Not yet recruiting
Shanghai Children's Medical Center
Shanghai
JiJian Zheng, 18964853803, zhengjijian626@sina.com
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang
Ping Zhao, 18940258971, zhaop@sj-hospital.org
- Not yet recruiting
West China Hospital and West China Second University Hospital
Sichuan
Yunxia Zuo, 8618980601541, zuoyunxia@scu.edu.cn
Australia2 sites, 2 recruiting
- Recruiting
Perth Children's Hospital
Nedlands
Britta von Ungern-Sternberg, +61426952977, lliana.slevin@health.wa.gov.au
- Not yet recruiting
Royal Children's Hospital
Parkville
Andrew Davidson, +61402271274, andrew.davidson@rch.org.au
India2 sites, 2 recruiting
- Not yet recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh
Indu Mohini Sen, 7087009532, sen.indumohini@pgimer.edu.in
- Not yet recruiting
Christian Medical College Hospital
Vellore
Ekta Rai, 9789250113, anaesthesia@cmcvellore.ac.in
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
São Paulo
Vinicius Quintao, 5511971273950, vinicius.quintao@hc.fm.usp.br
France1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants
Bordeaux
Jill Arthur, 33626964101, jill.arthur@chu-bordeaux.fr
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Great Ormond Street Hospital for Children
London
Richard Lin, 00447810447235, richard.lin@gosh.nhs.uk
About this study
The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are:
- The perioperative factors associated with occurrence of cerebral desaturation
- The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions.
Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.
Read the detailed description
The NIRS EEG sensors will be placed about an hour before surgery. The recording will start once sensors are placed, continue throughout the duration of surgery, and end 8-24 hours after end of surgery. Sensors will be removed at the end of recording. No additional anesthesia and/or sedation will be required for the preoperative and postoperative recordings. The EEG and NIRS monitors will be blinded to clinical staff. EEG and NIRS monitoring will not prolong anesthesia or the duration of the surgical repair, and should not interfere with routine patient care. NIRS and EEG data will be downloaded from the monitors at the end of recording for analysis.
Medical record review will be conducted at 100 days postop or hospital discharge (whichever is sooner). The information below will be extracted:
- Respiratory record
- Post-op recovery, ICU, and discharge records
- Cardiac and Neurologic records
- Neurologic test such as radiology and lab tests
- Mortality status
- Being tested
- NIRS/EEG monitoring
- Keywords
- Electroencephalography, Near-infrared spectroscopy
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS/EEG monitoringDevice
The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Infants | Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformations Receives: Device: NIRS/EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with perioperative cerebral desaturation
The incidence of cerebral desaturation in participants will be assessed by the Near-infrared Spectroscopy (NIRS) data recording of <70% and/or >10% decrease from baseline for > 3 minutes
Measured: 24 hours
Secondary outcomes (2)
Isoelectric EEG
Determined by EEG amplitude ≤ 10mV for ≥ 2 secs
Measured: up to 24 hours
Perioperative outcomes
Medical record review
Measured: up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start12 Aug 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
- Responsible party
- Sponsor
- Investigators
- Charles Dean Kurth, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673499
- Sponsor's protocol ID
- 22-019679
- Status last verified
- Apr 2026
- First submitted
- 21 Dec 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
CDC. https://www.cdc.gov/ncbddd/birthdefects/data.html. Accessed April 13, 2021.
Bonasso PC, Dassinger MS, Ryan ML, Gowen MS, Burford JM, Smith SD. 24-hour and 30-day perioperative mortality in pediatric surgery. J Pediatr Surg. 2019 Apr;54(4):628-630. doi: 10.1016/j.jpedsurg.2018.06.026. Epub 2018 Jun 25.
PubMed 30017066Laing S, Walker K, Ungerer J, Badawi N, Spence K. Early development of children with major birth defects requiring newborn surgery. J Paediatr Child Health. 2011 Mar;47(3):140-7. doi: 10.1111/j.1440-1754.2010.01902.x. Epub 2010 Nov 21.
PubMed 21091587Stolwijk LJ, Lemmers PM, Harmsen M, Groenendaal F, de Vries LS, van der Zee DC, Benders MJ, van Herwaarden-Lindeboom MY. Neurodevelopmental Outcomes After Neonatal Surgery for Major Noncardiac Anomalies. Pediatrics. 2016 Feb;137(2):e20151728. doi: 10.1542/peds.2015-1728. Epub 2016 Jan 12.
PubMed 26759411Tusor N, Benders MJ, Counsell SJ, Nongena P, Ederies MA, Falconer S, Chew A, Gonzalez-Cinca N, Hajnal JV, Gangadharan S, Chatzi V, Kersbergen KJ, Kennea N, Azzopardi DV, Edwards AD. Punctate White Matter Lesions Associated With Altered Brain Development And Adverse Motor Outcome In Preterm Infants. Sci Rep. 2017 Oct 16;7(1):13250. doi: 10.1038/s41598-017-13753-x.
PubMed 29038505Stolwijk LJ, Keunen K, de Vries LS, Groenendaal F, van der Zee DC, van Herwaarden MYA, Lemmers PMA, Benders MJNL. Neonatal Surgery for Noncardiac Congenital Anomalies: Neonates at Risk of Brain Injury. J Pediatr. 2017 Mar;182:335-341.e1. doi: 10.1016/j.jpeds.2016.11.080. Epub 2016 Dec 30.
PubMed 28043688Sood ED, Benzaquen JS, Davies RR, Woodford E, Pizarro C. Predictive value of perioperative near-infrared spectroscopy for neurodevelopmental outcomes after cardiac surgery in infancy. J Thorac Cardiovasc Surg. 2013 Feb;145(2):438-445.e1; discussion 444-5. doi: 10.1016/j.jtcvs.2012.10.033. Epub 2012 Dec 6.
PubMed 23219333Hoffman GM, Brosig CL, Mussatto KA, Tweddell JS, Ghanayem NS. Perioperative cerebral oxygen saturation in neonates with hypoplastic left heart syndrome and childhood neurodevelopmental outcome. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1153-64. doi: 10.1016/j.jtcvs.2012.12.060. Epub 2013 Jan 12.
PubMed 23317941Vida VL, Tessari C, Cristante A, Nori R, Pittarello D, Ori C, Cogo PE, Perissinotto E, Stellin G. The Role of Regional Oxygen Saturation Using Near-Infrared Spectroscopy and Blood Lactate Levels as Early Predictors of Outcome After Pediatric Cardiac Surgery. Can J Cardiol. 2016 Aug;32(8):970-7. doi: 10.1016/j.cjca.2015.09.024. Epub 2015 Oct 22.
PubMed 26868838Danzer E, Hoffman C, D'Agostino JA, Gerdes M, Bernbaum J, Antiel RM, Rintoul NE, Herkert LM, Flake AW, Adzick NS, Hedrick HL. Neurodevelopmental outcomes at 5years of age in congenital diaphragmatic hernia. J Pediatr Surg. 2017 Mar;52(3):437-443. doi: 10.1016/j.jpedsurg.2016.08.008. Epub 2016 Aug 30.
PubMed 27622588Birthdefects C. https://www.cdc.gov/ncbddd/birthdefects/data.html. Published 2021. Accessed April 21, 2021.
Escobar MA Jr, Caty MG. Complications in neonatal surgery. Semin Pediatr Surg. 2016 Dec;25(6):347-370. doi: 10.1053/j.sempedsurg.2016.10.005. Epub 2016 Nov 1.
PubMed 27989360Andropoulos DB, Ahmad HB, Haq T, Brady K, Stayer SA, Meador MR, Hunter JV, Rivera C, Voigt RG, Turcich M, He CQ, Shekerdemian LS, Dickerson HA, Fraser CD, Dean McKenzie E, Heinle JS, Blaine Easley R. The association between brain injury, perioperative anesthetic exposure, and 12-month neurodevelopmental outcomes after neonatal cardiac surgery: a retrospective cohort study. Paediatr Anaesth. 2014 Mar;24(3):266-74. doi: 10.1111/pan.12350.
PubMed 24467569Mahle WT, Tavani F, Zimmerman RA, Nicolson SC, Galli KK, Gaynor JW, Clancy RR, Montenegro LM, Spray TL, Chiavacci RM, Wernovsky G, Kurth CD. An MRI study of neurological injury before and after congenital heart surgery. Circulation. 2002 Sep 24;106(12 Suppl 1):I109-14.
PubMed 12354718Olbrecht VA, Skowno J, Marchesini V, Ding L, Jiang Y, Ward CG, Yu G, Liu H, Schurink B, Vutskits L, de Graaff JC, McGowan FX Jr, von Ungern-Sternberg BS, Kurth CD, Davidson A. An International, Multicenter, Observational Study of Cerebral Oxygenation during Infant and Neonatal Anesthesia. Anesthesiology. 2018 Jan;128(1):85-96. doi: 10.1097/ALN.0000000000001920.
PubMed 29019815
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
- ClinicalTrials.gov ID
- NCT05673499
- Acronym / sponsor ID
- 22-019679
- Keywords
- Electroencephalography, Near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are:
- The perioperative factors associated with occurrence of cerebral desaturation
- The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions.
Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.
Detailed description
The NIRS EEG sensors will be placed about an hour before surgery. The recording will start once sensors are placed, continue throughout the duration of surgery, and end 8-24 hours after end of surgery. Sensors will be removed at the end of recording. No additional anesthesia and/or sedation will be required for the preoperative and postoperative recordings. The EEG and NIRS monitors will be blinded to clinical staff. EEG and NIRS monitoring will not prolong anesthesia or the duration of the surgical repair, and should not interfere with routine patient care. NIRS and EEG data will be downloaded from the monitors at the end of recording for analysis.
Medical record review will be conducted at 100 days postop or hospital discharge (whichever is sooner). The information below will be extracted:
- Respiratory record
- Post-op recovery, ICU, and discharge records
- Cardiac and Neurologic records
- Neurologic test such as radiology and lab tests
- Mortality status
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants | – | Device: NIRS/EEG monitoringInfant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformations |
Who may qualify
- Ages
- Up to 60 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformat
Key inclusion criteria (4 listed)
- Infants ≤ 60 weeks post-menstrual age on day of surgery.
- Neonatal surgery for congenital abdominal/gastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid/pulmonary airway malformation (CCAM/CPAM), esophageal/tracheoesophageal fistula (EF/TEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma).
- The same patient may be enrolled multiple times for repeat or different procedures that meet the above criteria. These subjects will be counted more than once towards the enrollment goal.
- Parental/guardian permission.
Key exclusion criteria (1 listed)
- 1) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS/EEG monitoringThe study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery. | Device | Infants |
Primary outcome
Percentage of participants with perioperative cerebral desaturation
Time frame: 24 hours
The incidence of cerebral desaturation in participants will be assessed by the Near-infrared Spectroscopy (NIRS) data recording of <70% and/or >10% decrease from baseline for > 3 minutes
2 secondary outcomes
Isoelectric EEG
Time frame: up to 24 hours
Perioperative outcomes
Time frame: up to 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- BackgroundCDC. https://www.cdc.gov/ncbddd/birthdefects/data.html. Accessed April 13, 2021.
- Background: PubMed 30017066Bonasso PC, Dassinger MS, Ryan ML, Gowen MS, Burford JM, Smith SD. 24-hour and 30-day perioperative mortality in pediatric surgery. J Pediatr Surg. 2019 Apr;54(4):628-630. doi: 10.1016/j.jpedsurg.2018.06.026. Epub 2018 Jun 25.
- Background: PubMed 21091587Laing S, Walker K, Ungerer J, Badawi N, Spence K. Early development of children with major birth defects requiring newborn surgery. J Paediatr Child Health. 2011 Mar;47(3):140-7. doi: 10.1111/j.1440-1754.2010.01902.x. Epub 2010 Nov 21.
- Background: PubMed 26759411Stolwijk LJ, Lemmers PM, Harmsen M, Groenendaal F, de Vries LS, van der Zee DC, Benders MJ, van Herwaarden-Lindeboom MY. Neurodevelopmental Outcomes After Neonatal Surgery for Major Noncardiac Anomalies. Pediatrics. 2016 Feb;137(2):e20151728. doi: 10.1542/peds.2015-1728. Epub 2016 Jan 12.
- Background: PubMed 29038505Tusor N, Benders MJ, Counsell SJ, Nongena P, Ederies MA, Falconer S, Chew A, Gonzalez-Cinca N, Hajnal JV, Gangadharan S, Chatzi V, Kersbergen KJ, Kennea N, Azzopardi DV, Edwards AD. Punctate White Matter Lesions Associated With Altered Brain Development And Adverse Motor Outcome In Preterm Infants. Sci Rep. 2017 Oct 16;7(1):13250. doi: 10.1038/s41598-017-13753-x.
- Background: PubMed 28043688Stolwijk LJ, Keunen K, de Vries LS, Groenendaal F, van der Zee DC, van Herwaarden MYA, Lemmers PMA, Benders MJNL. Neonatal Surgery for Noncardiac Congenital Anomalies: Neonates at Risk of Brain Injury. J Pediatr. 2017 Mar;182:335-341.e1. doi: 10.1016/j.jpeds.2016.11.080. Epub 2016 Dec 30.
- Background: PubMed 23219333Sood ED, Benzaquen JS, Davies RR, Woodford E, Pizarro C. Predictive value of perioperative near-infrared spectroscopy for neurodevelopmental outcomes after cardiac surgery in infancy. J Thorac Cardiovasc Surg. 2013 Feb;145(2):438-445.e1; discussion 444-5. doi: 10.1016/j.jtcvs.2012.10.033. Epub 2012 Dec 6.
- Background: PubMed 23317941Hoffman GM, Brosig CL, Mussatto KA, Tweddell JS, Ghanayem NS. Perioperative cerebral oxygen saturation in neonates with hypoplastic left heart syndrome and childhood neurodevelopmental outcome. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1153-64. doi: 10.1016/j.jtcvs.2012.12.060. Epub 2013 Jan 12.
- Background: PubMed 26868838Vida VL, Tessari C, Cristante A, Nori R, Pittarello D, Ori C, Cogo PE, Perissinotto E, Stellin G. The Role of Regional Oxygen Saturation Using Near-Infrared Spectroscopy and Blood Lactate Levels as Early Predictors of Outcome After Pediatric Cardiac Surgery. Can J Cardiol. 2016 Aug;32(8):970-7. doi: 10.1016/j.cjca.2015.09.024. Epub 2015 Oct 22.
- Background: PubMed 27622588Danzer E, Hoffman C, D'Agostino JA, Gerdes M, Bernbaum J, Antiel RM, Rintoul NE, Herkert LM, Flake AW, Adzick NS, Hedrick HL. Neurodevelopmental outcomes at 5years of age in congenital diaphragmatic hernia. J Pediatr Surg. 2017 Mar;52(3):437-443. doi: 10.1016/j.jpedsurg.2016.08.008. Epub 2016 Aug 30.
- BackgroundBirthdefects C. https://www.cdc.gov/ncbddd/birthdefects/data.html. Published 2021. Accessed April 21, 2021.
- Background: PubMed 27989360Escobar MA Jr, Caty MG. Complications in neonatal surgery. Semin Pediatr Surg. 2016 Dec;25(6):347-370. doi: 10.1053/j.sempedsurg.2016.10.005. Epub 2016 Nov 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Dean Kurth, MD principal investigator
Children's Hospital of Philadelphia
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders and Cerebral Desaturation, run by Children's Hospital of Philadelphia at 15 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, China, Australia, India, Brazil and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula Hu, RN, MSPH (267-426-2961, hup@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with perioperative cerebral desaturation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05673499, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.