International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NIRS/EEG monitoring.
- Who it may be relevant to
- Registry conditions: Congenital Disorders, Cerebral Desaturation, Neonatal Surgery. Basic parameters: up to 60 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Brazil, China, France +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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
Interventions
- 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.
Primary outcome measures
- Percentage of participants with perioperative cerebral desaturation [Time frame: 24 hours]
Secondary outcome measures (2)
- Isoelectric EEG [Time frame: up to 24 hours]
- Perioperative outcomes [Time frame: up to 100 days]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- Children's Hospital at Montefiore/Albert Einstein College of Medicine — New York
- Children's Hospital of Philadelphia — Philadelphia
- Children's Medical Center Dallas — Dallas
- Children's Memorial Hermann Hospital — Houston
China · 4 centers
- Guangzhou women and children's medical center — Guangzhou
- Shanghai Children's Medical Center — Shanghai
- Shengjing Hospital of China Medical University — Shenyang
- West China Hospital and West China Second University Hospital — Sichuan
Australia · 2 centers
- Perth Children's Hospital — Nedlands
- Royal Children's Hospital — Parkville
India · 2 centers
- Post Graduate Institute of Medical Education and Research — Chandigarh
- Christian Medical College Hospital — Vellore
Brazil · 1 center
- Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo — São Paulo
France · 1 center
- Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants — Bordeaux
United Kingdom · 1 center
- Great Ormond Street Hospital for Children — London
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. PMID 30017066
- 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. PMID 21091587
- 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. PMID 26759411
- 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. PMID 29038505
- 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. PMID 28043688
- 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. PMID 23219333
- 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. PMID 23317941
Identifiers
NCT: NCT05673499 · 22-019679