Clinical trial NCT01671410: Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines
Official title: A Randomized, Open Label Clinical Trial of Buprenorphine in the Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines or Are Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neonatal Abstinence Syndrome
Keywords: Neonatal Abstinence Syndrome
buprenorphine
morphine
benzodiazepine
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of treatment
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
measure: Length of hospitalization
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: Number of patients requiring supplemental phenobarbital treatment
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Other outcomes:
measure: Feeding patterns
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: Respiratory Patterns
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Walter K Kraft, MD
role: PRINCIPAL_INVESTIGATOR
References: