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Набира участници NCT05673499

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

Заболявания: Congenital Disorders Cerebral Desaturation Neonatal Surgery

Спонсор: Children's Hospital of Philadelphia

Налично на: БГ
Обобщение
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.
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
Кой може да участва
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.
Интервенции
NIRS/EEG monitoring
DEVICE
Места на провеждане 15
Австралия (2)
Perth Children's Hospital
Nedlands
Royal Children's Hospital
Parkville
NOT_YET_RECRUITING
Бразилия (1)
Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
São Paulo
Китай (4)
Guangzhou women and children's medical center
Guangzhou
NOT_YET_RECRUITING
Shanghai Children's Medical Center
Shanghai
NOT_YET_RECRUITING
Shengjing Hospital of China Medical University
Shenyang
NOT_YET_RECRUITING
West China Hospital and West China Second University Hospital
Sichuan
NOT_YET_RECRUITING
Франция (1)
Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants
Bordeaux
NOT_YET_RECRUITING
Индия (2)
Post Graduate Institute of Medical Education and Research
Chandigarh
NOT_YET_RECRUITING
Christian Medical College Hospital
Vellore
NOT_YET_RECRUITING
Великобритания (1)
Great Ormond Street Hospital for Children
London
NOT_YET_RECRUITING
САЩ (4)
Children's Medical Center Dallas
Dallas , Texas
NOT_YET_RECRUITING
Children's Memorial Hermann Hospital
Houston , Texas
NOT_YET_RECRUITING
Children's Hospital at Montefiore/Albert Einstein College of Medicine
New York , New York
NOT_YET_RECRUITING
Children's Hospital of Philadelphia
Philadelphia , Pennsylvania
Charles Dean Kurth, MD
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Максимална възраст
60 Weeks
Здрави доброволци
Не
Начална дата
12.08.2022
Крайна дата
31.12.2027
Регистрационен номер
NCT05673499
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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