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:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT01726166
Eligibility Criteria:
Inclusion criteria (to be approached for consent):
-All infants who are admitted to the NICU and are not known to have the exclusion criteria listed below at the time of admission
Exclusion criteria (to be approached for consent):
* Antenatal detection or suspicion of genitourinary anomaly including: ambiguous genitalia, hypospadias, posterior urethral valve, anal atresia, exstrophy-epispadias complex, and oligohydramnios secondary to probable genitourinary anomaly(e.g. renal agenesis, multicystic kidney disease)
* Antenatal hydrops
* Antenatally detected abdominal wall defect or abdominal masses
* Antenatally detected grossly dilated bowel loops
* Congenital abdominal skin lesion over the SPA puncture site
Inclusion criteria (prior to randomization):
-All infants who are greater than 72 hours of age, who are being investigated for a possible UTI, and have been consented will be eligible for randomization
Exclusion criteria (prior to randomization):
* Oliguria (\<0.5 cc/kg/hr) or anuria over the 8 hours prior to attempted urine collection
* Skin infection over the SPA puncture site
* Distension or enlargement of abdominal viscera (e.g. grossly dilated loops of bowel or massive organomegaly)
* Active Necrotizing enterocolitis (Bell stage II or more)
* Uncorrected thrombocytopenia (platelets \< 50 x 10 6) or bleeding diathesis
* Post-abdominal surgery
* Large inguinal hernia
* Current pre-existing indwelling catheter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
72 Hours
Maximum Age:
12 Months
Study:
NCT01726166
Study Brief:
Protocol Section:
NCT01726166