Improving Outcomes in Neonatal Abstinence Syndrome

• Status: Completed
• Trial end date: 2018-08-30
• Target enrollment: 0
• Participant gender: All

Summary

1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied. Infants will be randomized to receive either morphine or methadone. It is hypothesized that morphine treated infants will do better and require fewer days in the hospital compared to methadone treated infants.

2. SPECIFIC Aim II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants will be evaluated with development testing at 18 months of age. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes. It is also hypothesized that neurobehavioral abnormalities identified at two weeks of age will correlate with neurodevelopmental impairment at 18 months.

3: SPECIFIC Aim III: To determine if common genetic variations in the genes involving narcotic action contribute to the severity of NAS. A DNA sample will be obtained from all infants and analyzed for differences in 3 key genes. This will then be correlated with short-term and long-term outcomes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Methadone; Morphine; Pharmaceutical Solutions; Phenobarbital

Criteria

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.