Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
About this trial
Last updated 2 years ago
Study ID
ACTNOW-02
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
36+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 5 years ago
What is this trial about?
The objective of this study is to evaluate the efficacy of a rapid wean intervention compared
with a slow-wean intervention in reducing the number of days of opioid treatment from the
first dose of weaning to cessation of opioid among infants receiving an opioid (defined as
morphine or methadone) as the primary treatment for neonatal opioid withdrawal syndrome
(NOWS).
What are the participation requirements?
Inclusion Criteria
- Hospital Level
1. Hospital provides pharmacologic treatment to at least an average of 12 opioid exposed infants each year
2. Hospital uses a scoring system to assess for signs of NOWS (original or modified Finnegan Neonatal Abstinence Scoring system, Eat-Sleep or Console)
3. Hospital provides opioid replacement therapy with either morphine or methadone as part of pharmacologic treatment of NOWS
- Infant Level
1. Gestational age ≥ 36 weeks
2. Receiving scheduled pharmacological therapy with morphine or methadone as the primary drug treatment for NOWS secondary to maternal opioid use
3. Tolerating enteral feeds and medications by mouth
Exclusion Criteria
- Hospital Level
1. Hospitals discharge > 10% of infants from the hospital on opioid replacement therapy on average per year
- Infant Level
1. Major birth defect (e.g. gastroschisis)
2. Any major surgery (minor surgery [e.g., circumcision, digit ligation, frenulectomy] is not an exclusion criterion)
3. Hypoxic-ischemic encephalopathy
4. Seizures from etiologies other than NOWS
5. Treatment with opioids for reasons other than NOWS
6. Respiratory support (nasal cannula or greater) for > 72 hours
7. Planned discharge from the hospital on opioids
8. Use of other opioids (e.g., buprenorphine) as primary drugs for treatment of NOWS
9. Weaning of morphine or methadone as the primary treatment of NOWS has started
Locations
Location
Status
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting