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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT02583360
Eligibility Criteria:
Inclusion Criteria:
* Infants with feeding-related aero-digestive symptoms
* ≤60 weeks PMA (both pre-term and full term)
* History of orally feeding ≥ 25% of least 50% of prescribed feeding volume
* Room air or supplemental oxygen of ≤1liter/minute (LPM)
Exclusion Criteria:
* Direct breast feeding exclusively
* Known genetic, metabolic or syndromic disease
* Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH), moderate to severe perinatal asphyxia or stroke
* Craniofacial, airway or foregut malformations
* History of craniofacial, foregut, ears, nose and throat (ENT) or neurosurgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
38 Weeks
Maximum Age:
60 Weeks
Study:
NCT02583360
Study Brief:
Protocol Section:
NCT02583360