Please select the eligibility criteria that correspond to the clinical trial below.
Title: Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
Brief Summary: Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS.

This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.


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:

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
C: 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
D: Inclusion Criteria:

* Current opioid dependence
* Current opioid use, as determined by a urine drug test
* Pregnant with a single child with a gestational age of 6 to 30 weeks, as determined by a sonogram

Exclusion Criteria:

* Current medical condition that would make study participation dangerous, as determined by study physician
* Diagnosed with an acute, severe psychiatric illness
* Current SCID I-E module diagnosis of benzodiazepine or alcohol abuse
* Use of alcohol or benzodiazepines in the 30 days prior to study entry, as determined by the Addiction Severity Index
* Pending legal action that may prohibit or interfere with study participation

Answer: C