Improving Outcomes in Neonatal Abstinence Syndrome
Status:
Completed
Trial end date:
2018-08-30
Target enrollment:
Participant gender:
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.