Overview

Clonidine for Neonatal Abstinence Syndrome Study

Status:
Terminated
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baystate Medical Center
Treatments:
Clonidine
Phenobarbital
Criteria
Inclusion Criteria:

- 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 Criteria:

- Gestational age < 35 weeks

- Intrauterine growth retardation (birth weight below the 5th percentile)

- Congenital heart disease

- Congenital anomalies

- Medically unstable

Exposure to Benzodiazepines prenatally

-