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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT01091805
Eligibility Criteria:
Inclusion Criteria:
1. Pediatric patients from birth to 18 years (including premature infants) who are deemed clinically to require 24 hour esophageal pH/impedance.
2. Pediatric patients (newborn to 18 years) undergoing MBS who have had or will have pH/MII monitoring within 6 months.
3. Patients' parents or legal guardians will provide written informed consent for the protocol. When appropriate, patient assent will be obtained.
Exclusion Criteria:
1. Patients with anatomic facial anomalies or facial discomfort precluding nasal intubation of the pH/MII catheter.
2. Patient unable to complete a 24 hour pH/MII study.
3. Children fed exclusively with nasogastric or nasojejunal (transpyloric) tube at the time of study.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT01091805
Study Brief:
Protocol Section:
NCT01091805