Safety and Feasibility of Indocyanine Green Fluorescence for Intraoperative Assessment of Intestinal Perfusion in Young Infants and Neonates

The goal of this clinical trial is to test the use of the SPY-PHI device for the purpose of ICG-mediated intestinal perfusion visualization during gastrointestinal surgery in neonates and young infants (<3 months old) undergoing surgery for NEC, atresia, SIP or malrotation. The main question[s] it aims to answer are:Is ICG-FA feasible for intraoperative use in neonates and young infants undergoing laparotomy for NEC, atresia, SIP or malrotation?Is ICG-FA is safe to use in neonates during surgery?Participants will undergo surgical care for their diseases within the standard of care. During laparotomy, the pediatric surgeon will assess bowel perfusion in two ways. First, by visual inspection (the conventional method). Second, the intestine will be analyzed with indocyanine green fluorescence angiography (ICG-FA) by means of the hand-held SPY-PHI camera. For this purpose, the patients will be administered ICG intravenously. Afterwards, the intestinal perfusion will be assessed by means of the SPY-PHI device in 5 to 10 minutes.Specifically, the feasibility and safety for use of ICG-FA in neonates undergoing laparotomy as treatment for necrotizing enterocolitis (NEC), atresia, spontaneous intestinal perforation (SIP) and malrotation will be investigated.If ICG-FA turns out to be feasible and safe for the population investigated in this study, a follow-up study will be conducted with the aim to explore the potential benefits of this technique on the postoperative outcome and intraoperative decision-making.

Inclusion Criteria:Written informed consent is obtained by both patient's parents or legal guardians (as applicable);Patient is a neonate (< 1 month of age) or young infant (<3 months of age);Patient is suffering from necrotizing enterocolitis, atresia, malrotation or spontaneous intestinal perforation;Patient requires laparotomy for management of the disease.Exclusion Criteria:Patient is suffering from clinically significant (treatment necessary) hyperbilirubinemia;Patient is suffering from thyroid or liver disease;Patient is allergic to the active substance indocyanine green or sodium iodide or iodine;Patient has abdominal wall defects;Patient can be treated non-surgically;During the preoperative multidisciplinary meeting with the team, including the pediatric anesthetist, patient is deemed not stable enough hemodynamically to perform the ICG-FU measurementsPatient is assessed unstable by operating team intraoperatively.