The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by \~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Oral morphine for the treatment of neonatal abstinence syndrome
Sublingual buprenorphine for the treatment of neonatal abstinence syndrome
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Length of treatment
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Length of hospitalization
This endpoint will compare length of stay (in days) using sublingual buprenorphine or oral morphine
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Number of patients requiring supplemental phenobarbital treatment
This endpoint will compare requirement number of patients who require use of supplemental phenobarbital for treatment of NAS
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Number of participants with adverse events as a measure of safety and tolerability
Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.