Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial

To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.

• neonates born at gestational age of 35 weeks or greater
• neonates aged 0 to 14 days
• prenatally exposed to opioids
• severe NAS defined as 2 consecutive modified Finnegan Scores (MFS) > or = 9

Exclusion Criteria:

• < 35 weeks gestational age
• Intrauterine growth retardation defined as <5%tile of gestational age
• postnatal treatment with barbiturates or benzodiazepines,
• major congenital anomalies
• major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
• breastfed infants