Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

ACTNOW-02

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).

2020-09-08

2024-01-31

2026-06-30

Active (not recruiting)

Early phase I

190

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will have two intervention arms (rapid-wean and slow-wean) with 251 morphine/methadone treated infants per intervention arm, for a total of 502 morphine/methadone treated infants.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The pharmacy will track dose levels to know where an infant is within a rapid- or slow-wean intervention arm. The clinical team will be blinded to the dose level and will only be aware of the study steps. Both the rapid- and slow-wean intervention arms are depicted to indicate that if each intervention arm has the same number of escalations, the study steps will be identical. This is critical to maintaining the clinical team blinding.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 190, 'type': 'ACTUAL'}}

2024-02-28