Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome

National Institute on Drug Abuse (NIDA)80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neonatal Abstinence Syndrome

Interventions

Clonidine HCLDRUG

Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm

Eligibility

Sex: ALLMax age: 14 Days

Medical Language ↔ Plain English

* 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

Locations (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Length of treatment for neonatal abstinence syndrome

Time frame: duration of the treatment

Data from ClinicalTrials.gov

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