Status:
TERMINATED
Clonidine for Neonatal Abstinence Syndrome Study
Lead Sponsor:
Baystate Medical Center
Conditions:
Neonatal Abstinence Syndrome
Eligibility:
All Genders
Up to 15 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Introduction: Neonatal abstinence syndrome (NAS) is a symptom complex experienced by 55 to 94% of neonates who are exposed to intrauterine opioids. Recent studies have shown that combination therapies...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Gestational age \< 35 weeks
- Intrauterine growth retardation (birth weight below the 5th percentile)
- Congenital heart disease
- Congenital anomalies
- Medically unstable
- Exposure to Benzodiazepines prenatally
- \-
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01175668
Start Date
July 1 2010
End Date
October 1 2012
Last Update
January 6 2014
Active Locations (1)
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1
NICU @ Baystate Children's Hospital
Springfield, Massachusetts, United States, 01199