Please select the eligibility criteria that correspond to the clinical trial below.
Title: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Brief Summary: Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").


Options:
A: Inclusion Criteria:

Eligible subjects are infants currently inpatient in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital and:

* Full-term infants (\>37 wks gestational age) and late preterm infants (34-37 wks gestational age)
* Newborns at risk for NAS due to fetal-drug exposure
* At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report (documented in medical chart review) for opioids (e.g., methadone, buprenorphine/subutex, oxycodone, heroin); may also have prenatal exposure to benzodiazepines, barbiturates, amphetamines, cannabinoids, alcohol, nicotine and/or caffeine.

Exclusion Criteria:

Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:

* Born less than \<34 weeks.
* Has a congenital abnormality
* Has a fetal anomaly
* Has hydrocephalus or intraventricular hemorrhage \>grade 2
* Has a seizure disorder not related to drug withdrawal
* Has a clinically significant shunt
* Requires mechanical respiratory support
B: Inclusion Criteria:

Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender:

* Admitted to the NICU immediately postpartum
* Gestational age 28 weeks or older
* No identified hearing disorder
* Do not have a diagnosed developmental disability (i.e. Down Syndrome)
* Do not have Fetal Alcohol Syndrome
* Medically cleared to participate in the study by nurse or neonatologist
* Parent or legal guardian able/willing to give consent \& complete the PBQ (Postpartum Bonding Questionnaire)

Exclusion Criteria:

* Admitted to the NICU at any time other than immediately postpartum
* Gestational age \<28 weeks old
* Has an identified hearing disorder
* Has diagnosed developmental disability (i.e. Down syndrome)
* Has Fetal Alcohol Syndrome
* Is not medically cleared to participate in the study by the nurse or neonatologist
* Parent or legal guardian unable/unwilling to give consent
C: Inclusion Criteria:

i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores \> 8 in an 8 hour time period, AND

ii. Gestation =\> 35 weeks at entry defined by best obstetrical and physical exam criteria, AND

iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND

iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.

Exclusion Criteria:

i. Gestation \< 35 weeks at entry defined by best obstetrical and physical exam criteria.

ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,

iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.

iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course

v. Mother consistently taking prescribed benzodiazepine at the time of delivery
D: Inclusion Criteria:

* ≥ 37 weeks gestation
* exposure to opiates in utero
* demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

Exclusion Criteria:

* major congenital malformations and/or intrauterine growth retardation
* medical illness requiring intensification of medical therapy
* concomitant benzodiazepine or severe alcohol abuse, self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother during pregnancy,
* concomitant use of CYP 3A inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, HIV protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of NAS treatment
* seizure activity or other neurologic abnormality
* breast feeding
* inability of mother to give informed consent due to co-morbid psychiatric diagnosis
* hypoglycemia requiring treatment with intravenous glucose

Answer: D