Clonidine for Neonatal Abstinence Syndrome Study

Stopped early · Not applicable

Conditions studied: Neonatal Abstinence Syndrome

In brief

The study plans to compare the use of Clonidine versus Phenobarbital as an additional medication to neonatal morphine sulfate for treatment of newborn infants undergoing drug withdrawal symptoms due to mother's use of opioid drug use. The investigators hypothesis is that use of Clonidine will lead to shorter duration of treatment, hospital stay and thereby early discharge home.

Key facts

Study ID

NCT01175668

Run by

Baystate Medical Center

People needed

68

Starts

2010-07-01

Expected to finish

2012-10-01

Last updated by the study team

2014-01-06

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 0 to 15 days of age
• Prenatal exposure to opioids with development of moderate to severe NAS (2 consecutive abstinence scores of ≥ 8)
• Medically stable

You may not qualify if…

• Gestational age < 35 weeks
• Intrauterine growth retardation (birth weight below the 5th percentile)
• Congenital heart disease
• Congenital anomalies
• Medically unstable
• Exposure to Benzodiazepines prenatally

Where it is running

• NICU @ Baystate Children's Hospital — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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