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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT01667120
Eligibility Criteria:
Inclusion Criteria:
1. Infants gestational age \> 37 weeks and greater than or equal to one week of age to 3 months of age
2. Infants who are undergoing a surgical procedure on the abdomen
3. the parent or guardian has given informed consent.
Exclusion Criteria:
1. Gestational age \< 37 weeks
2. Age less than one week or greater than 3 months of age
3. Known renal disease/dysplastic kidneys
4. Serum Creatinine \> 0.4
5. Patients who have rising creatinine levels the day prior to surgery (increase of at least 1.5-fold from baseline)
6. Patients who are currently receiving other potentially renal toxic drugs or drugs that may interfere with hemostatic pathways as part of their clinical care (including but not limited to furosemide, hydrochlorothiazide, vancomycin, gentamicin, aspirin, tpa \[except for use of thrombosed central venous catheters\], enalapril, systemic heparin \[except for use in central venous catheter flushes\])
7. Patients who undergo nephrectomy
8. Patients with necrotizing enterocolitis
9. Patients with a hemoglobin value \< 10g/dL
10. Recent (within 3 months) GI bleeding, ulceration, and/or perforation
11. Platelet count \< 50,000
12. Ongoing disseminated intravascular coagulation or history of intraventricular hemorrhage
13. Recent (within 2 weeks) use or current use of other nonsteroidal anti-inflammatory drugs (NSAIDS) besides aspirin (ASA)
14. Allergy to ASA or other NSAIDS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Week
Maximum Age:
3 Months
Study:
NCT01667120
Study Brief:
Protocol Section:
NCT01667120