Overview

Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)

Status:
Recruiting
Trial end date:
2025-08-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Methadone
Morphine
Criteria
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