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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT04455802
Eligibility Criteria:
Inclusion Criteria:
1. Infant gestational age greater than or equal 36 weeks
2. Mother receiving either methadone from a drug treatment program, buprenorphine from a licensed physician, or an opioid prescription for a documented medical need
3. Mother had at least 2 prenatal appointments.
4. Infant toleration of oral medication administration
5. Infant is considered medically stable by the attending physician
6. Singleton Pregnancy
7. English Speaking
Exclusion Criteria:
1. Within 30 days of birth the mother has actively used illicit drugs (excluding THC) or obtaining oral opioids, methadone, or buprenorphine from a non-licensed physician or drug treatment program
2. The mother has had less than 2 prenatal care visits
3. The mother reports excessive alcohol use during pregnancy
4. Mother is less than 18 years of age or is not capable of signing consent
5. The infant has a gestational age less than or equal to 35 weeks and 6 days
6. The infant has dysmorphic features including evidence of aneuploidy
7. The infant is not able to tolerate oral medication administration
8. Multiple gestation pregnancy
9. Hypoxic-ischemic encephalopathy
10. Seizures from etiologies other than NOWS
11. Non-English Speaking
12. Infant started on NOWS standard care medication prior to study consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04455802
Study Brief:
Protocol Section:
NCT04455802