A Pilot Study into the Use of Intraoperative Indocyanine Green Fluorescence Angiography in Young Infants & Neonates

• Conditions: Surgical gastrointestinal disorders; Disorders of the gastrointestinal system requiring surgery; 10018031; 10017998

• Registration Number: NL-OMON56951
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified