International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 18
- 主要终点
- Percentage of participants with perioperative cerebral desaturation
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 60 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •1) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.
研究组 & 干预措施
Infants
Infant subjects ≤ 60 weeks post-menstrual age who are undergoing surgery for congenital malformations
干预措施: NIRS/EEG monitoring (Device)
结局指标
主要结局
Percentage of participants with perioperative cerebral desaturation
时间窗: 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
次要结局
- Perioperative outcomes(up to 100 days)
- Isoelectric EEG(up to 24 hours)