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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05902104
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of intestinal failure with PN dependence
* Hospitalized at Boston Children's Hospital
* Age: 60 days to 18 months
* Corrected gestational age: greater than or equal to 40 weeks
* Weight: greater than or equal to 4kg
* Likely to proceed to PN cycling within the next month, as assessed by the clinical team
Exclusion Criteria:
* Underlying medical conditions or medications that predispose to hypoglycemia or hyperglycemia (e.g. insulin administration, systemic glucocorticoids, hyperinsulinism, adrenal insufficiency, other metabolic diseases)
* Diffuse skin disease such that placement of a CGM sensor would be unsafe or difficult to secure
* Known history of allergy or severe reaction to the adhesive/tape that is used to secure the CGM
* Diffuse body edema that would limit accuracy of CGM sensor
* Poor peripheral perfusion or use of vasoactive agents that would limit accuracy of CGM sensor
* Use of medications that interfere with CGM accuracy (e.g. Hydroxyurea, acetaminophen at more than a maximum dose of 1 g every 6 hours up to 4 g every 24 hours)
* Enrolled in competing clinical trial
* Ward of the state
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
18 Months
Study:
NCT05902104
Study Brief:
Protocol Section:
NCT05902104