Clinical trial
Prospective Randomized Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Name
WIH 19-0042
Description
This randomized control trial will compare buprenorphine and morphine, two currently used medications for the treatment of neonatal opioid withdrawal syndrome (NOWS), in newborns to determine which medication will reduce the number of days of pharmacological treatment.
Trial arms
Trial start
2020-10-01
Estimated PCD
2021-05-17
Trial end
2021-05-17
Status
Withdrawn
Phase
Early phase I
Treatment
Buprenorphine or Placebo
The double blind, double dummy design necessitates that both drugs be on an identical schedule. The 4-hour dosing allows for this pairing. If a patient is randomized to the buprenorphine arm, medication administration will follow an every 8-hour dosing but medication will be substituted with placebo during the intermediary time point.
Arms:
Buprenorphine, Morphine
Morphine or Placebo
If a patient is randomized to the morphine arm, morphine will be given every 4 hours. Placebo will also be given at the same frequency as a faux drug.
Arms:
Buprenorphine, Morphine
Primary endpoint
Total amount of opioid medication for treatment of NOWS
Duration of pharmacological treatment with opioid medication while admitted to the hospital up to 30 days
Eligibility criteria
Inclusion Criteria:
1. Infant gestational age greater than or equal 36 weeks
2. Mother receiving either methadone from a drug treatment program, buprenorphine from a licensed physician, or an opioid prescription for a documented medical need
3. Mother had at least 2 prenatal appointments.
4. Infant toleration of oral medication administration
5. Infant is considered medically stable by the attending physician
6. Singleton Pregnancy
7. English Speaking
Exclusion Criteria:
1. Within 30 days of birth the mother has actively used illicit drugs (excluding THC) or obtaining oral opioids, methadone, or buprenorphine from a non-licensed physician or drug treatment program
2. The mother has had less than 2 prenatal care visits
3. The mother reports excessive alcohol use during pregnancy
4. Mother is less than 18 years of age or is not capable of signing consent
5. The infant has a gestational age less than or equal to 35 weeks and 6 days
6. The infant has dysmorphic features including evidence of aneuploidy
7. The infant is not able to tolerate oral medication administration
8. Multiple gestation pregnancy
9. Hypoxic-ischemic encephalopathy
10. Seizures from etiologies other than NOWS
11. Non-English Speaking
12. Infant started on NOWS standard care medication prior to study consent
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Infants will be randomly assigned to treatment arms of either morphine or buprenorphine', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The study will be a randomized, double-blind, double-dummy, intention-to-treat clinical trial. All clinical providers, research personnel and participants will be blinded to group assignment. Pharmacy personnel will be the only un-blinded individuals. The placebo medication will be identical in appearance and volume to a dose of the medication at the respective dose.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-06-22
1 organization
2 products
1 indication
Organization
Women and Infants Hospital of Rhode IslandProduct
BuprenorphineIndication
Neonatal Opioid Withdrawal SyndromeProduct
Morphine