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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT04299867
Eligibility Criteria:
Inclusion Criteria:
1. Age 0 to 2 years at enrollment
2. Written informed consent provided by a parent or legal guardian
3. Scheduled to undergo elective intestinal operation for the removal of non-infected bowel
4. Sufficient intravascular access to complete the study procedures
Exclusion Criteria:
1. Prior treatment with metronidazole for any dose during the 72 hours prior to study drug administration.
2. Patients with active inflammatory or infectious conditions of the bowel such as inflammatory bowel disease, Hirschprung's disease in the portion of bowel to be excised, diverticular disease, cancerous or pre-cancerous lesions, colitis, enteritis, ulcerative disease, Meckel's diverticulum, celiac disease, and irritable bowel syndrome.
3. Renal dysfunction defined as serum creatinine \>2 mg/dL at enrollment
4. Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
5. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
2 Years
Study:
NCT04299867
Study Brief:
Protocol Section:
NCT04299867