Use of Indocyanine Green and Near Infrared Fluorescence to Assess Oesophageal Repair in Babies with Atresia and Distal Tracheo-oesophageal Fistula

What this Trial Is About

This research aims to evaluate the use of Indocyanine Green (ICG) combined with near infrared fluorescence (NIRF) imaging in babies undergoing primary or delayed primary repair of oesophageal atresia with distal tracheo-oesophageal fistula (OA/dTOF). The study investigates whether ICG/NIRF can reduce the rates of anastomotic leaks or predict which patients might develop these leaks, potentially allowing better counseling of parents and guiding further preventive strategies. Additionally, the study will assess how ICG affects peripheral oxygen and cerebral near infrared spectroscopy readings during surgery in neonates. Participants will receive ICG during their surgery, with both intravenous and enteral dosing to evaluate tissue blood flow before and after the oesophageal anastomosis. The study will observe if ICG/NIRF can identify poor blood flow or ischemia at the surgical site, which is linked to leak risk. The research includes a single treatment arm and is designed as a cohort pilot study with 20 patients to inform a future multi-center randomized trial. During the study, researchers will monitor oxygen saturation and near-infrared spectroscopy values in the babies, comparing them with arterial blood oxygen measurements from routine blood gas analysis. The main outcomes measured within two weeks after surgery will be the intravenous and enteral ICG assessments. Secondary measures include follow-up evaluations of oxygen saturation and clinical outcomes within a year. This study will last until March 2026 and is sponsored by Birmingham Women's and Children's NHS Foundation Trust.

Use of Indocyanine Green During Primary Repair of Oesophageal Atresia and Distal Tracheo-oesophageal Fistula