Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate
Brief Summary: The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.


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:

* Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) \>or= 35 wks
* Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)
* Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment

Exclusion Criteria:

* Seizures
* Major congenital malformations
* Unlikely to survive
* Parents not able to understand English
D: 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

Answer: C