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 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT00395161
Eligibility Criteria:
Inclusion Criteria:
During the initial accrual period for this study, prior to the first interim analysis, patients will be eligible for enrollment if they:
* are between 12 months and less than 18 years; AND
* are within the first 48 hours of the PICU admission; AND
* have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND
* are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.
After the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves enrollment of infants after the first interim analysis, then patients will be eligible for enrollment if they:
* are between 40 weeks gestational age and less than 18 years; AND
* are within the first 48 hours of the PICU admission; AND
* have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND
* are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.
Exclusion Criteria:
During the initial accrual period for this study, prior to the first interim analysis, patients will be ineligible for enrollment if ANY of the following is true or anticipated:
* are less than 1 year age; OR
* are greater than or equal to 18 years of age; OR
* have a known allergy to metoclopramide; OR
* planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR
* suspected intestinal obstruction, OR
* intestinal surgery or bowel disruption, OR
* chronic metoclopramide therapy prior to enrollment, OR
* failure to enroll within 48 hours of PICU admission, OR
* readmission to PICU in the previous 28 days, OR
* previously enrolled in this study, OR
* lack of commitment to aggressive intensive care therapies.
After the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves enrollment of infants after the first interim analysis, then patients will be ineligible for enrollment if ANY of the following is true or anticipated:
* are less than 40 weeks gestational age; OR
* are greater than or equal to 18 years of age; OR
* have a known allergy to metoclopramide; OR
* planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR
* suspected intestinal obstruction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
17 Years
Study:
NCT00395161
Study Brief:
Protocol Section:
NCT00395161