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NAS Trial


Title Improving outcome in neonatal abstinence syndrome with included sub-study: Establishing Risk in Neonatal Abstinence Syndrome (NAS) Genomics Component
Therapeutic Area Neonatal Conditions (Floating), Neonatal Abstinence Syndrome
Principal Investigator Jonathan Davis, MD
Min Age 0 Years
Max Age 4 Years
Gender Both
Contact Julie Burt
781-927-5608
More Information https://clinicaltrials.gov/ct2/show/NCT01958476

Overview

The purpose of this research study is to find better ways to treat infants with Neonatal Abstinence Syndrome (NAS) and improve long-term outcome. The goal is to compare two common drugs and see which one works the best.

Study Details

Inclusion Criteria

  • Mother receiving methadone or BPH from a licensed physician or drug treatment program, or an opiod prescribed by a licensed health care worker for treatment of chronic pain (urine toxicology will be performed on the mother and meconium on the newborn infant at the time of delivery to detect other antenatal drug exposure)
  • Need for treatment of NAS by Finnegan Scoring criteria
  • Gestational age ≥37 weeks at birth defined by best obstetrical estimate (NAS is rare in preterm infants; preterm infants also have longer LOS, more neurodevelopmental impairment, and respond to lower doses of medication than term infants which would increase the variability in outcomes and reduce the power for the present trial)

Exclusion Criteria

  • 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

Study Requirements

Monthly follow-up phone calls, 18 month clinic visit, genetics component