Neonatal Abstinence Syndrome
Conditions
Keywords
Neonatal Abstinence Syndrome, buprenorphine, morphine, benzodiazepine
Brief summary
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.
Detailed description
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.
Interventions
DRUGoral morphine
Oral morphine for the treatment of neonatal abstinence syndrome
Sublingual buprenorphine for the treatment of neonatal abstinence syndrome
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. ≥ 37 weeks gestation 2. Exposure to opioids in utero 3. Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment 4. Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.
Exclusion criteria
1. Major congenital malformations and/or intrauterine growth retardation defined as birth weight \<2200 gm 2. Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy. 3. Hypoglycemia requiring treatment with intravenous dextrose 4. Bilirubin \>20 mg/dL (The need for phototherapy is not exclusionary) 5. Seizure activity or other neurologic abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of treatment | Patients will be followed for the duration of hospital stay, an expected average of 5 weeks | This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | Patients will be followed for the duration of hospital stay, an expected average of 5 weeks | This endpoint will compare length of stay (in days) using sublingual buprenorphine or oral morphine |
| Number of patients requiring supplemental phenobarbital treatment | Patients will be followed for the duration of hospital stay, an expected average of 5 weeks | This endpoint will compare requirement number of patients who require use of supplemental phenobarbital for treatment of NAS |
| Number of participants with adverse events as a measure of safety and tolerability | Patients will be followed for the duration of hospital stay, an expected average of 5 weeks | Adverse events will be collected, graded by severity, and assessed for causality referent to study drug. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feeding patterns | Patients will be followed for the duration of hospital stay, an expected average of 5 weeks | To compare the feeding patterns, weight gain, and incidence of feeding dysfunction in infants treated with sublingual buprenorphine and oral morphine for NAS |
| Respiratory Patterns | Patients will be followed for the duration of hospital stay, an expected average of 5 weeks | To compare the respiratory patterns of infants receiving sublingual buprenorphine or morphine solution for the pharmacologic treatment of NAS after in utero exposure to opioids and benzodiazepines and/or postnatal breast milk. |
Countries
United States
Outcome results
None listed