Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Music Therapy on Newborns
Brief Summary: The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).


Options:
A: 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
B: Inclusion Criteria:

* Infants of corrected gestational age ≥37 weeks
* Chronic opioid exposure in utero
* Signs and symptoms of NAS requiring treatment
* 2 consecutive Finnegan scores ≥8 or any single score ≥12

Exclusion Criteria:

* Concomitant maternal benzodiazepine or alcohol use 30 days prior to enrollment
* Life-threatening congenital malformations
* Intrauterine growth retardation
* Seizure activity or congenital neurologic abnormalities
* Concomitant neonatal use of Cytochrome P450 inhibitor or inducers prior to treatment
* Inability of mother's consent due to altered mental status or comorbid psychiatric disorder
* Neonatal administration of morphine prior to enrollment into study
C: 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.
D: Inclusion Criteria:

1. Admitted to the NICU or newborn nursery
2. Corrected gestational age 34 weeks or older
3. No identified hearing disorder
4. Do not have a diagnosed developmental disability (i.e. Down Syndrome)
5. Do not have Fetal Alcohol Syndrome
6. Medically cleared to participate in the study
7. Parent or legal guardian able/willing to give consent \& complete surveys.

Exclusion Criteria:

1. Corrected gestational age \< 34 weeks old
2. Has an identified hearing disorder
3. Has diagnosed developmental disability (i.e. Down syndrome)
4. Has Fetal Alcohol Syndrome
5. Is not medically cleared to participate in the study
6. Parent or legal guardian unable/unwilling to give consent

Answer: D