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Active, not recruiting No phase listed Observational Accepts healthy volunteers

ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study

NCT04149509
Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
Not listed
Lead sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Network
Eligibility
Up to 1 Month
Enrollment
300 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2026
U.S. locations
6
States / cities
Birmingham, Alabama • Washington D.C., District of Columbia • Durham, North Carolina + 3 more
Conditions
Neonatal Opiate Withdrawal Syndrome
Interventions
Finnegan Neonatal Abstinence Scoring Tool, Eat, Sleep, Console (ESC) care tool
Other
Lead sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Network
Eligibility
Up to 3 Days
Enrollment
1,305 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
26
States / cities
Newark, Delaware • Tampa, Florida • Honolulu, Hawaii + 21 more
Conditions
Neonatal Opioid Withdrawal Syndrome
Interventions
Morphine, Methadone
Drug
Lead sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Network
Eligibility
36 Weeks and older
Enrollment
189 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
24
States / cities
Birmingham, Alabama • Tucson, Arizona • Little Rock, Arkansas + 18 more