Study Stopped
Based on the planned interim analysis results at 50% recruitment, after IRB reviewed the results, further enrollment was stopped.
Clonidine for Neonatal Abstinence Syndrome Study
Comparison of Clonidine Versus Phenobarbital as an Adjunct Therapy for Neonatal Abstinence Syndrome
1 other identifier
interventional
68
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 14, 2010
CompletedFirst Posted
Study publicly available on registry
August 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
January 6, 2014
CompletedJanuary 6, 2014
November 1, 2013
2.1 years
July 14, 2010
September 3, 2013
November 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Length of Treatment With Neonatal Morphine Sulfate
subjects were followed for the duration of treatment, up to 3 months
Secondary Outcomes (1)
Total Dose of NMS Used
For the duration of treatment, upto 3 months
Study Arms (2)
NMS/Clonidine
EXPERIMENTALNMS/Phenobarbital
ACTIVE COMPARATORInterventions
This group of infants undergoing NAS will be treated with neonatal morphine sulfate and Clonidine as an adjunct medication to control the symptoms. Once stable Finnegan scores \<8 for 24h, NMS will be weaned by 10% daily till off, then Clonidine will be weaned off in a stepwise manner. Infant will not go home on any medication for NAS. NMS will be dosed as mg/kd/day divided q3h and Clonidine will be dosed as microgm/kg/day divided q6h based upon the initial Finnegan scores.
Infants in this arm will be treated as current standard practice with NMS and Phenobarbital. NMS will be weaned by 10% daily to completely off during the hospital stay. Infants will be discharged home on Phenobarbital. NMS will be dosed as mg/kg/day divided q3h and Phenobarbital will be dosed as mg/kg/day divided q8h based on the Finnegan scores.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NICU @ Baystate Children's Hospital
Springfield, Massachusetts, 01199, United States
Related Publications (1)
Surran B, Visintainer P, Chamberlain S, Kopcza K, Shah B, Singh R. Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial. J Perinatol. 2013 Dec;33(12):954-9. doi: 10.1038/jp.2013.95. Epub 2013 Aug 15.
PMID: 23949834RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
One of the major limitations to our study was the inability to blind the two groups for the study medications.
Results Point of Contact
- Title
- Rachana Singh, MD
- Organization
- Baystate Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Rachana Singh, MD, MS
Baystate Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
July 14, 2010
First Posted
August 5, 2010
Study Start
July 1, 2010
Primary Completion
August 1, 2012
Study Completion
October 1, 2012
Last Updated
January 6, 2014
Results First Posted
January 6, 2014
Record last verified: 2013-11