Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Active-Control, Double-Blind, Double-Dummy Clinical Trial Comparing Sublingual Buprenorphine And Morphine Solution For The Treatment Of Neonatal Opioid Abstinence Syndrome
Brief Summary: The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a \~30% reduction length of treatment compared to standard of care morphine. Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is needed to unequivocally establish the superiority of buprenorphine over morphine. The primary objective of the trial is to compare length of treatment using sublingual buprenorphine or oral morphine solution in the pharmacologic treatment of the NAS.


Options:
A: Inclusion Criteria:

* Evidence of opioid withdrawal clinically as defined by 2 NAS scores \>8 or 1 NAS score \>12 over a 4 to 8 hour time period, AND
* Gestation \>=35 weeks at entry defined by best obstetrical and physical exam criteria, AND
* Medically stable condition, other than in opioid withdrawal, in the opinion of the attending neonatologist, AND EITHER,
* Meconium or urine drug screen positive for opioids on mother or newborn, OR
* Known maternal prescription of opioids for chronic pain management during at least the last trimester of pregnancy, OR
* Known maternal prescription of opioids for treatment of addiction, OR
* Suspected or admitted abuse with opioid drugs
* Infants of mothers with a medical or psychiatric diagnosis will not be excluded, unless the maternal diagnosis precludes informed consent

Exclusion Criteria:

* Gestation \<35 weeks at entry defined by best obstetrical and physical exam criteria.
* Hypoglycemia, hypomagnesaemia, or hypocalcaemia until corrected.
* Serious medical illness such as sepsis, pneumonia, hyperthyroidism, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.
* Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course.
B: 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. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
* Hypoglycemia requiring treatment with intravenous dextrose.
* Bilirubin \>20 mg/dL (The need for phototherapy is not exclusionary)
* 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 30 days prior to birth,
* Concomitant use of Cytrochrom (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
C: 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
D: Inclusion Criteria:

* Intrauterine exposure of opiate and related drugs-morphine
* Late preterm or full term (36-42 weeks of gestation)

Exclusion Criteria:

* Major congenital anomalies
* Post-surgical cases
* Major respiratory, cardiovascular, neurological or metabolic disorders
* Less than 36 completed weeks of gestation

Answer: B