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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT05129020
Eligibility Criteria:
Inclusion Criteria
1. Neonates or infants \>33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy
2. Clinically stable without respiratory support (exception for nasal cannula)
3. Congenital syndromes may be included if the infants do not have major, unrepaired anomalies
Exclusion Criteria
1. Unstable infants
2. Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving
3. Major unrepaired congenital anomalies impacting respiratory or cardiovascular system
4. Cardiomyopathy
5. Abnormal ear anatomy preventing the device to fit
6. Infants diagnosed with iatrogenic NOWS
7. Infants two weeks of age or older (after birth)
8. Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing
9. Infants who are wards of the state
10. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
33 Weeks
Maximum Age:
1 Year
Study:
NCT05129020
Study Brief:
Protocol Section:
NCT05129020