Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) (NCT04214834) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
United States189 participantsStarted 2020-09-28
Plain-language summary
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).
Who can participate
Age range36 Weeks
SexALL
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Inclusion criteria
✓. Hospital provides pharmacologic treatment to at least an average of 12 opioid exposed infants each year
✓. Hospital uses a scoring system to assess for signs of NOWS (original or modified Finnegan Neonatal Abstinence Scoring system, Eat-Sleep or Console)
✓. Hospital provides opioid replacement therapy with either morphine or methadone as part of pharmacologic treatment of NOWS
✓. Gestational age ≥ 36 weeks
✓. Receiving scheduled pharmacological therapy with morphine or methadone as the primary drug treatment for NOWS secondary to maternal opioid use
✓. Tolerating enteral feeds and medications by mouth
Exclusion criteria
✕. Major birth defect (e.g. gastroschisis)
✕. Any major surgery (minor surgery \[e.g., circumcision, digit ligation, frenulectomy\] is not an exclusion criterion)
✕. Hypoxic-ischemic encephalopathy
✕. Seizures from etiologies other than NOWS
✕. Treatment with opioids for reasons other than NOWS
✕. Respiratory support (nasal cannula or greater) for \> 72 hours
✕. Planned discharge from the hospital on opioids
What they're measuring
1
Days of Opioid Treatment From First Wean to Cessation
Timeframe: From the start of opioid study medication until weaning. Infants exited the study intervention without unblinding (remained in the trial) by 35 days from the first weaning dose. Outcome truncated at 35 days regardless of the study arm.
Trial details
NCT IDNCT04214834
SponsorAdvancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program