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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT00120159
Eligibility Criteria:
Inclusion Criteria:
Patients must meet at least one criterion from each of the following three categories:
Historical Factors:
* Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6cc/kg or any aspirate containing bile
* Apneic/bradycardic episodes
* Oxygen desaturation episode not otherwise explained
* Guaiac positive or grossly bloody stools
Physical Examination Findings:
* Abdominal distention recorded by practitioner
* Capillary refill time greater than 2 seconds
* Abdominal wall discoloration
* Abdominal tenderness
Radiographic Findings:
* Pneumatosis intestinalis
* Portal venous gas
* Ileus
* Dilated bowel
* Pneumoperitoneum
* Air/fluid levels
* Thickened bowel walls
* Ascites or peritoneal fluid
* Free intraperitoneal air
Exclusion Criteria:
Patients will be excluded for any of the following:
* Major gastrointestinal anomaly
* Prior abdominal operation
* Family does not consent to participate (A list of patients for whom consent was refused will be maintained in order to avoid contacting these families repeatedly. All families who refuse consent will be queried as to the reason for refusal).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
2 Years
Study:
NCT00120159
Study Brief:
Protocol Section:
NCT00120159