Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
Brief Summary: To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.


Options:
A: 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
B: * neonates born at gestational age of 35 weeks or greater
* neonates aged 0 to 14 days
* prenatally exposed to opioids
* severe NAS defined as 2 consecutive modified Finnegan Scores (MFS) \> or = 9

Exclusion Criteria:

* \< 35 weeks gestational age
* Intrauterine growth retardation defined as \<5%tile of gestational age
* postnatal treatment with barbiturates or benzodiazepines,
* major congenital anomalies
* major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
* breastfed infants
C: 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
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: B