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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT01962818
Eligibility Criteria:
Inclusion Criteria:
* Infants at 24-36 weeks corrected gestational age
* Already ventilated with high frequency ventilation
* Requiring FiO2=21%-70% to maintain adequate oxygen saturation.
* Clinical stable
o i.e. ventilated on current settings for more than just a few hours with stable but not necessarily normalized blood gases or transcutaneous values and oxygen requirement.
* Parent(s) or guardian able and willing to provide informed consent
Exclusion Criteria: • Major congenital cardiovascular or respiratory abnormalities (excluding Patent ductus arteriosus).
* Poor skin integrity precluding use of adhesive ECG electrodes used for EIT monitoring.
* The physician responsible for the baby considers one of the ventilation modes unsuitable for the infant or the patient unsuitable for EIT monitoring.
* Lack of parental signed written informed consent or if both parents are under 18 years of age (due to complexities of obtaining consent).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
44 Weeks
Study:
NCT01962818
Study Brief:
Protocol Section:
NCT01962818