Clinical Trial: Improving Outcomes in Neonatal Abstinence Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Improving Outcomes in Neonatal Abstinence Syndrome

Brief 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.


Detailed Summary:

1: SPECIFIC AIM I: To compare the short term efficacy of morphine and methadone for the treatment of NAS. One hundred eighty four term infants with a diagnosis of NAS requiring pharmacotherapy will be studied. Infants born to mothers receiving adequate prenatal care and maintained on opioid agonist medication during pregnancy will be eligible. Infants will be randomized to receive either neonatal morphine solution or methadone in a double blind, double dummy design. It is hypothesized that morphine treated infants will require significantly fewer days in the hospital compared to methadone treated infants. While the primary outcome is the total length of initial hospital stay (LOS), total LOS related to NAS, total duration of medical treatment for NAS, the need for a second drug to control symptoms, and infant growth will also be evaluated as important secondary outcomes by medication group assignment.

2. SPECIFIC AIM II: To evaluate the effects of NAS treatment on long-term neurodevelopmental outcome. Infants in both treatment groups will be evaluated at 18 months of age using the Bayley III Scales of Infant Development. It is hypothesized that morphine treated infants will have better neurodevelopmental outcomes at 18 months compared to methadone treated infants. It is also hypothesized that neurobehavioral abnormalities (from either treatment group) identified at two weeks of age using the NICU Network Neurobehavioral Scale (NNNS) will correlate with neurodevelopmental impairment detected with the Bayley III. Early identification of infants at highest risk for impaired development will facilitate therapeutic interventions to improve outcome and decrease resource utilization.

3: SPECIFIC AIM III: To determine if single nucleotide polymorphisms (SNPs) in genes controlling opioid pharmacodynamics contribute to the severity
Sponsor: Tufts Medical Center

Current Primary Outcome: Length of hospital stay [ Time Frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 22 days ]

Participants will be monitored for the duration of their hospitalization for neonatal abstinence syndrome, which is an expected mean of 22 days


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total opioid days [ Time Frame: Participants will be monitored for the duration of their hospitalization, expected mean 22 days ]
    Total number of days infant treated with replacement opioids while in the hospital
  • Maximum daily dose of replacement opioid [ Time Frame: Participants will be monitored until the end of their hospitalization, expected mean 22 days ]
    Maximum daily dose of neonatal morphine solution or methadone during the hospitalization
  • Mean Finnegan Score [ Time Frame: Participants will be monitored during their entire hospitalization, expected mean 22 days ]
    Mean Finnegan withdrawal score during the hospitalization
  • Need for a second NAS medication [ Time Frame: Participants will be monitored during their entire hospitalization, expected mean 22 days ]
    Need for a second medication to control opioid withdrawal


Original Secondary Outcome: Same as current

Information By: Tufts Medical Center

Dates:
Date Received: August 14, 2013
Date Started: September 2013
Date Completion: December 2017
Last Updated: May 9, 2017
Last Verified: May 2017