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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT03052361
Eligibility Criteria:
Inclusion Criteria:
* Children aged more than 6 months and weight ≥ 8kg
* At least 4 non-bilious, non-bloody vomiting in the preceding 24 hours
* The last vomiting occured less than 2 hours ago
* No other diagnostic more likely than gastroenteritis suspected by the nurse at triage.
Exclusion Criteria:
* Severe dehydration (based on poor capillary refill or hypotension)
* Underlying disease that could affect the assessment of hydration (such as renal failure or hypoalbuminemia)
* Bilious or bloody vomiting
* Bloody stool
* A history of abdominal surgery
* Allergy to ondansetron
* Long QT syndrome or major cardiac condition
* Previous enrolment in the study.
* Girl at risk of pregnancy (pubertal girl)
* Inability to obtain parental informed consent (language barrier, absence, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT03052361
Study Brief:
Protocol Section:
NCT03052361