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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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.

Первичные конечные точки

• Percentage of participants with perioperative cerebral desaturation [Срок оценки: 24 hours]

Вторичные конечные точки (2)

• Isoelectric EEG [Срок оценки: up to 24 hours]
• Perioperative outcomes [Срок оценки: up to 100 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

1\) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• 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

Китай · 4 центра

• Guangzhou women and children's medical center — Гуанчжоу
• Shanghai Children's Medical Center — Шанхай
• Shengjing Hospital of China Medical University — Шэньян
• West China Hospital and West China Second University Hospital — Sichuan

Австралия · 2 центра

• Perth Children's Hospital — Nedlands
• Royal Children's Hospital — Parkville

Индия · 2 центра

• Post Graduate Institute of Medical Education and Research — Chandigarh
• Christian Medical College Hospital — Vellore

Бразилия · 1 центр

• Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo — São Paulo

Франция · 1 центр

• Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants — Bordeaux

Великобритания · 1 центр

• Great Ormond Street Hospital for Children — London

Публикации

• 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

Идентификаторы

NCT: NCT05673499 · 22-019679

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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