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:

1. Mother receiving methadone or buprenorphine (BPH) from a licensed physician or drug treatment program, or an opioid prescribed by a licensed health care worker for treatment of chronic pain.
2. Need for treatment of NAS by Finnegan Scoring criteria
3. Gestational age \>37 weeks at birth defined by best obstetrical estimate
4. Medically stable in the opinion of the Attending Physician
5. Mother receiving "adequate" or "intermediate" prenatal care from a qualified physician or midwife as defined by the Prenatal Care Adequacy Index
6. Singleton pregnancy
7. Mother able to provide informed consent
8. Infant able to take oral medications

Exclusion criteria:

1. Gestation \<37 weeks at entry defined by best obstetrical estimate
2. Major congenital abnormalities including genetic syndromes
3. Serious medical illness such as sepsis, asphyxia, seizures, or respiratory failure
4. Mother abusing alcohol during pregnancy (average of 3 or more drinks per week in the last 30 days)
5. Multiple gestations
6. Mother received "inadequate" prenatal care as defined by the Prenatal Care Adequacy Index.
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:

* 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: D