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 @ 2:34 PM
Ignite Modification Date:
2025-12-24 @ 2:34 PM
NCT ID:
NCT02224859
Eligibility Criteria:
Inclusion Criteria:
1. Have a parent(s) or guardian(s) who has provided written informed consent for the patient to participate in the study.
2. Be \> 30.0 weeks gestational age at time of enrollment into the study
3. Be in medically stable condition within the NICU
4. Be able to breathe adequately on room air without support
5. Be deemed suitable (i.e., in no acute distress) for participating in the study for approximately six (6) hours, in the investigator's opinion
6. Upon visual inspection have intact skin without breaks and/or lacerations of the scalp or adjacent areas where the CSD will fit
Exclusion Criteria:
1. The use of any additional respiratory support (i.e., intubation, using CPAP, etc.) is required,
2. The patient has any genetic dermatological conditions
3. The patient's head size is not appropriate for the device \< 28 centimeters or \>34.3 centimeters (\< 11 or \> 13.5 inches)
4. Patient has significant medical condition(s) (e.g., encephalocele, IVH, Shunt, etc.) that makes participating in the study not in the patient's best interest
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Weeks
Maximum Age:
36 Weeks
Study:
NCT02224859
Study Brief:
Protocol Section:
NCT02224859