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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05874102
Eligibility Criteria:
Inclusion Criteria:
* The age of the infant at the time of the study must be between 38 to 56 weeks post-menstrual age (PMA) (American Academy of Pediatrics, 2004; Balest et al., 2021, Han et al. 2020; McGratten et al., 2020).
* Infant has been referred for an MBS by their physician based on clinical need (suspected oropharyngeal dysphagia)
* Only infants with confirmed pharyngeal dysphagia, as defined by at least one airway invasion event on their MBS, will be included in final data analysis
Exclusion Criteria:
* Infants who are deemed not medically stable enough to complete an MBS
* Infants who are deemed unable to maintain a side-lying or upright position for at least 3 minutes
* Infants who do not meet the inclusion criteria above
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
38 Weeks
Maximum Age:
56 Weeks
Study:
NCT05874102
Study Brief:
Protocol Section:
NCT05874102