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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT02007759
Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Meet diagnostic criteria for dysphagia symptoms using the NOMAS and a VFSS.
* Infants with intraventricular hemorrhage (IVH) and hypoxic events can be included.
* Infants taking less than 5-10% of target volume by mouth between the ages of 36-42 weeks PCA.
* Multiple swallows to clear bolus following suck that includes a desaturation \<80% and bradycardia \<80 bpm.
* Apnea spells during feeds.
* Aspiration or penetration by VFSS
Exclusion Criteria:
* Known neurologic or neurodegenerative disorders.
* Chromosomal anomalies and syndromes.
* Cleft lip or palate.
* Birth defects.
* Unresolved cutaneous rash at the area of electrode placement.
* Medical condition that is a contraindication to NMES.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Weeks
Maximum Age:
42 Weeks
Study:
NCT02007759
Study Brief:
Protocol Section:
NCT02007759