Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
NAS
Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2002
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 31, 2007
CompletedFirst Posted
Study publicly available on registry
August 1, 2007
CompletedJanuary 11, 2017
July 1, 2007
July 31, 2007
January 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of treatment for neonatal abstinence syndrome
duration of the treatment
Study Arms (1)
Clonidine treatment
EXPERIMENTALInfants intrauterine exposed to opioids (heroin or methadone) that demonstrate signs and symptoms of withdrawal with withdrawal scores (modified Finnegan score) greater than 9 on to consecutive scores taken 4 hours apart.
Interventions
Duraclon 1 microgram/kg every 4 hours given p.o. as per algorithm
Eligibility Criteria
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Drug Abuse (NIDA)lead
- Johns Hopkins Universitycollaborator
Study Sites (1)
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287-3200, United States
Related Publications (3)
Hoder EL, Leckman JF, Poulsen J, Caruso KA, Ehrenkranz RA, Kleber HD, Cohen DJ. Clonidine treatment of neonatal narcotic abstinence syndrome. Psychiatry Res. 1984 Nov;13(3):243-51. doi: 10.1016/0165-1781(84)90039-8.
PMID: 6597462BACKGROUNDGold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9. doi: 10.1016/s0140-6736(80)92295-3. No abstract available.
PMID: 6107698BACKGROUNDAgthe AG, Kim GR, Mathias KB, Hendrix CW, Chavez-Valdez R, Jansson L, Lewis TR, Yaster M, Gauda EB. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. Pediatrics. 2009 May;123(5):e849-56. doi: 10.1542/peds.2008-0978. Epub 2009 Apr 27.
PMID: 19398463DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Estelle B Gauda, M.D.
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 31, 2007
First Posted
August 1, 2007
Study Start
July 1, 2002
Study Completion
December 1, 2005
Last Updated
January 11, 2017
Record last verified: 2007-07