Improving Outcomes in Neonatal Abstinence Syndrome

Completed · Phase 3 · Has a placebo group

Conditions studied: Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal

In brief

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.

Key facts

Study ID

NCT01958476

Run by

Tufts Medical Center

People needed

117

Starts

2013-09-01

Expected to finish

2018-08-30

Last updated by the study team

2019-10-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Need for treatment of NAS by Finnegan Scoring criteria
• Gestational age >37 weeks at birth defined by best obstetrical estimate
• Medically stable in the opinion of the Attending Physician
• Mother receiving "adequate" or "intermediate" prenatal care from a qualified physician or midwife as defined by the Prenatal Care Adequacy Index
• Singleton pregnancy
• Mother able to provide informed consent
• Infant able to take oral medications

You may not qualify if…

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

Where it is running

• Shands Jacksonville Medical Center — Jacksonville, Florida, United States
• Maine Medical Center — Portland, Maine, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Women and Infant's Hospital of Rhode Island — Providence, Rhode Island, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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