Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 326 for:    clonidine

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670160
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Tennessee Medical Center

Brief Summary:
The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Drug: Phenobarbital Drug: Clonidine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Phenobarbital
Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.
Drug: Phenobarbital
Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge.

Active Comparator: Clonidine
Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.
Drug: Clonidine
Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.




Primary Outcome Measures :
  1. Time from initiation of adjunctive therapy until hospital discharge [ Time Frame: From date of randomization until hospital discharge, up to 4 months ]
    Number of days from initiation of adjunctive therapy until hospital discharge


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: From date of randomization until hospital discharge, up to 4 months ]
    Number of days of hospital admission

  2. Length of oral morphine sulfate therapy [ Time Frame: From date of randomization until hospital discharge, up to 4 months ]
    Number of days of oral morphine sulfate therapy

  3. Percentage of patients requiring triple therapy [ Time Frame: From date of randomization until hospital discharge, up to 4 months ]
    Number of patients requiring a third agent to control withdrawal symptoms

  4. Safety-Number of patients who experienced symptoms of excessive sedation, hypotension, bradycardia or hypertension which required dose modification of study agents [ Time Frame: From date of randomization until 30 days after discontinuation of study medication, up to 6 months. ]
    Number of patients who experienced symptoms of excessive sedation, hypotension, bradycardia or hypertension which required dose modification of study agents

  5. Readmission Rate [ Time Frame: From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months ]
    Number of patients readmitted to the hospital within 30 days of hospital discharge or discontinuation of phenobarbital.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants greater than or equal to 35 weeks gestation age
  • Admitted to the neonatal intensive care unit
  • Failed monotherapy with morphine sulfate therapy

Exclusion Criteria:

  • Neonatal abstinence syndrome due to iatrogenic causes
  • Unable to take oral medications at any point during their treatment
  • Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670160


Contacts
Layout table for location contacts
Contact: Carrie Brusseau, PharmD 865-305-9120 cbrussea@utmck.edu
Contact: Tara Burnette, MD 865-305-9834 tburnett@utmck.edu

Locations
Layout table for location information
United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Carrie A Brusseau, PharmD    865-305-6711    cbrussea@utmck.edu   
Sponsors and Collaborators
University of Tennessee Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Carrie Brusseau, PharmD University of Tennessee Medical Center

Layout table for additonal information
Responsible Party: University of Tennessee Medical Center
ClinicalTrials.gov Identifier: NCT03670160     History of Changes
Other Study ID Numbers: UHS-OB-0001
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Clonidine
Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Phenobarbital
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
GABA Modulators
GABA Agents