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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT01281566
Eligibility Criteria:
Inclusion Criteria:
* Must be hospitalized and on continuous cardiac monitoring for the duration of the study
* Patient has demonstrated feeding intolerance as defined by the protocol
* Patient's parent or legal guardian must sign the informed consent form
Exclusion Criteria:
* Currently active significant cardiovascular disease, as determined by the neonatologist/physician, including congenital heart disease and heart block (patent ductus arteriosus without cardiac compromise at the time of randomization is acceptable)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Weeks
Maximum Age:
99 Weeks
Study:
NCT01281566
Study Brief:
Protocol Section:
NCT01281566