International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

Congenital Disorders Clinical Trial

Official title:

International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673499
• Other study ID #: 22-019679
• Status: Recruiting
• Start date: August 12, 2022
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Children's Hospital of Philadelphia
• Contact: Paula Hu, RN, MSPH
• Phone: 267-426-2961
• Email: hup[@]chop.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: N/A to 60 Weeks

Eligibility

Inclusion Criteria:

1. Infants = 60 weeks post-menstrual age on day of surgery.

2. 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).

3. 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.

4. Parental/guardian permission. Exclusion Criteria: 1) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.

Related Conditions & MeSH terms

• Cerebral Desaturation
• Congenital Disorders
• Neonatal Surgery

Intervention

Device:
• NIRS/EEG monitoring
The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.

Locations

Country	Name	City	State
Australia	Perth Children's Hospital	Nedlands
Australia	Royal Children's Hospital	Parkville
Brazil	Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo	São Paulo
China	Guangzhou women and children's medical center	Guangzhou
China	Shanghai Children's Medical Center	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang
China	West China Hospital and West China Second University Hospital	Sichuan
France	Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants	Bordeaux
India	Post Graduate Institute of Medical Education and Research	Chandigarh
India	Christian Medical College Hospital	Vellore
United Kingdom	Great Ormond Street Hospital for Children	London
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Children's Memorial Hermann Hospital	Houston	Texas
United States	Children's Hospital at Montefiore/Albert Einstein College of Medicine	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Masimo Corporation

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  China,  France,  India,  United Kingdom, 

References & Publications (20)

Andropoulos 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. — View Citation

Birthdefects C. https://www.cdc.gov/ncbddd/birthdefects/data.html. Published 2021. Accessed April 21, 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. — View Citation

CDC. https://www.cdc.gov/ncbddd/birthdefects/data.html. Accessed April 13, 2021.

Danzer 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. — View Citation

Dent CL, Spaeth JP, Jones BV, Schwartz SM, Glauser TA, Hallinan B, Pearl JM, Khoury PR, Kurth CD. Brain magnetic resonance imaging abnormalities after the Norwood procedure using regional cerebral perfusion. J Thorac Cardiovasc Surg. 2006 Jan;131(1):190-7. doi: 10.1016/j.jtcvs.2005.10.003. — View Citation

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. — View Citation

Hoffman 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. — View Citation

Kurth CD, Levy WJ, McCann J. Near-infrared spectroscopy cerebral oxygen saturation thresholds for hypoxia-ischemia in piglets. J Cereb Blood Flow Metab. 2002 Mar;22(3):335-41. doi: 10.1097/00004647-200203000-00011. — View Citation

Laing 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. — View Citation

Mahle 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. — View Citation

Olbrecht 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. — View Citation

Sood 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. — View Citation

Stolwijk 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. — View Citation

Stolwijk 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. — View Citation

Suemori T, Skowno J, Horton S, Bottrell S, Butt W, Davidson AJ. Cerebral oxygen saturation and tissue hemoglobin concentration as predictive markers of early postoperative outcomes after pediatric cardiac surgery. Paediatr Anaesth. 2016 Feb;26(2):182-9. doi: 10.1111/pan.12800. Epub 2015 Dec 1. — View Citation

Tusor 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. — View Citation

Vida 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. — View Citation

Yuan I, Olbrecht VA, Mensinger JL, Zhang B, Davidson AJ, von Ungern-Sternberg BS, Skowno J, Lian Q, Song X, Zhao P, Zhang J, Zhang M, Zuo Y, de Graaff JC, Vutskits L, Szmuk P, Kurth CD. Statistical Analysis Plan for "An international multicenter study of isoelectric electroencephalography events in infants and young children during anesthesia for surgery". Paediatr Anaesth. 2019 Mar;29(3):243-249. doi: 10.1111/pan.13589. Erratum In: Paediatr Anaesth. 2020 Jun;30(6):730. — View Citation

Yuan I, Xu T, Kurth CD. Using Electroencephalography (EEG) to Guide Propofol and Sevoflurane Dosing in Pediatric Anesthesia. Anesthesiol Clin. 2020 Sep;38(3):709-725. doi: 10.1016/j.anclin.2020.06.007. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Secondary	Isoelectric EEG	Determined by EEG amplitude = 10mV for = 2 secs	up to 24 hours
Secondary	Perioperative outcomes	Medical record review	up to 100 days