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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT04419857
Eligibility Criteria:
Infant Inclusion Criteria:
* Infants with NAS born to mothers age 18-45 with methadone exposure before or during pregnancy who do not intend to place their infants for adoption
* Infants \> 2200 g Infants at least 36 weeks gestational age
* Delivered at: Yale New Haven Hospital
* Mothers/infants able to return to outpatient pediatric provider for 2 month and 4 month weights visits
Infant Exclusion Criteria:
* Infants with major congenital malformations
* Infants enrolled to NICU \>24 hours for medical conditions other than NAS treatment before 3 days of life
Mother's Inclusion criteria -
* Pregnant women (age 18-45) who have started methadone treatment at obstetrics or other YNHH appointments
* Confirm methadone treatment is received from a licensed treatment program
* Confirm that mothers are planning to deliver their infant(s) at Yale New Haven Hospital
* Confirm that mothers do not intend to place the infant(s) for adoption
* Confirm mother's willingness to participate in the study (including attending the 2-month and 4-month follow up weigh-ins with pediatrician)
* Consent forms will be signed and faxed to study staff
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04419857
Study Brief:
Protocol Section:
NCT04419857