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Opioid Analgesic
Buprenorphine for Neonatal Opioid Withdrawal Syndrome
Phase 3
Waitlist Available
Led By Adam J Czynski, DO
Research Sponsored by Women and Infants Hospital of Rhode Island
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months old
Awards & highlights
Study Summary
This trial will compare buprenorphine and morphine to see which is better at treating neonatal opioid withdrawal syndrome.
Eligible Conditions
- Neonatal Opioid Withdrawal Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months old
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months old
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total amount of opioid medication for treatment of NOWS
Secondary outcome measures
Cognitive, Language, and Motor Development From 18 Month Old Bayley Neurodevelopmental Assessment
Length of stay secondary to NOWS
Length of total stay
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BuprenorphineExperimental Treatment2 Interventions
Infants randomized to the buprenorphine arm will be started on a dose of 10 mg/kg/dose every 8 hours. A morphine placebo will also be given at the same frequency as a faux drug.
Patients can only be randomized to only one arm.
Group II: MorphineActive Control2 Interventions
Infants randomized to the morphine arm will start at a dose of 0.06 mg/kg/dose every 4 hours. A buprenorphine placebo will also be given at the same frequency as a faux drug.
Find a Location
Who is running the clinical trial?
Women and Infants Hospital of Rhode IslandLead Sponsor
109 Previous Clinical Trials
38,600 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,760 Total Patients Enrolled
Adam J Czynski, DOPrincipal InvestigatorWomen and Infants Hospital
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Did the Federal Drug Administration give Buprenorphine the okay for public use?
"There is both efficacy and safety data from prior clinical trials, so Buprenorphine received a score of 3."
Answered by AI
How can I join the clinical trial?
"Unfortunately, this particular study is no longer seeking new participants. Although, according to clinicaltrials.gov, there are 1461 other trials that are still recruiting."
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