NL-OMON56951尚未招募不适用
A Pilot Study into the Use of Intraoperative Indocyanine Green Fluorescence Angiography in Young Infants & Neonates - IMAGINE Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 1（—）
入选标准
- •1. Written informed consent is obtained by both patient*s parents or legal
- •guardians (as applicable);
- •2. Patient is a neonate (< 1 month of age) or young infant (<3 months of age);
- •3. Patient is suffering from necrotizing enterocolitis, intestinal atresia,
- •malrotation or spontaneous intestinal perforation;
- •4. Patient requires laparotomy for management of the disease.
排除标准
- •General exclusion criteria
- •1. Patient is suffering from clinically significant (treatment necessary)
- •hyperbilirubinemia;
- •2. Patient is suffering from thyroid or liver disease;
- •3. Patient is allergic to the active substance indocyanine green or sodium
- •iodide or iodine;
- •4. Patient has abdominal wall defects;
- •5. Patient can be treated non-surgically;
- •6. During the preoperative multidisciplinary meeting with the team, including
- •the pediatric anesthetist, patient is deemed not stable enough hemodynamically
- •to perform the ICG-FA measurements
- •Intra-operative exclusion criterium
- •7. Patient is assessed unstable by operating team intraoperatively.
研究者
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