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Clinical Trials/NL-OMON56951
NL-OMON56951
Not yet recruiting
Not Applicable

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

niversitair Medisch Centrum Groningen0 sites20 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgical gastrointestinal disorders
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
20
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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