Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT05734118
Eligibility Criteria:
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 measurements
* Patient is assessed unstable by operating team intraoperatively.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
3 Months
Study:
NCT05734118
Study Brief:
Protocol Section:
NCT05734118