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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT01870635
Eligibility Criteria:
Inclusion Criteria:
* Age 6 - 59 months (0.5 - 5 years)
* Symptoms consistent with gastroenteritis (must have a \& b)
1. 1 episode of nonbilious, nonbloody vomiting within the 4 hours preceding triage The requirement for only 1 vomiting episode is based on prior work which similarly required 1 vomiting episode within 4 hours of triage. The later study reported a 17% absolute reduction in the use of IV rehydration. The vast majority of children seeking care and enrolled in the aforementioned study had a significantly greater number of vomiting episodes in the preceding 24 hour (mean \>9 episodes).
2. Presence of ≥ 1 episode of diarrhea during the illness We require the presence of only 1 diarrheal stool to enhance our probability of enrolling children with enteritis (as opposed to other diagnoses). In fact, of the 8 RCTs performed using antiemetics in children with gastroenteritis in developed countries, only 1 even required the presence of any diarrhea as part of the eligibility criteria (and that study required a single diarrheal stool).
* Presence of NO dehydration (NO=not enough signs to classify as some or severe dehydration)
Exclusion Criteria:
* Weight \<8 kg
* Vomiting or diarrhea for \> 7 days
* Malnutrition: The World Health Organization (WHO) definition will be employed - weight for height below -3z scores of the median WHO growth standards
* Severe dehydration (WHO criteria) or hypotension defined as a systolic blood pressure \<70 mm Hg in infants 1 month to 12 months, \< 70 mm Hg + (2 x age in years) in children 1-10 years, \< 90 mm Hg in children ≥ 10 years
* Prior abdominal surgery (excluding hernia)
* Bilious or bloody vomitus
* Known hypersensitivity to ondansetron or any serotonin receptor antagonist
* History or family history of prolonged QT syndrome
* Taking apomorphine or any medication that is generally accepted as having a risk of causing torsades de pointes
* Patients previously enrolled in the study
* Follow-up will not be possible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT01870635
Study Brief:
Protocol Section:
NCT01870635