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Trial record 41 of 328 for:    clonidine

Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy

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ClinicalTrials.gov Identifier: NCT03092011
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Alla Kushnir, The Cooper Health System

Brief Summary:
The purpose of this study is to determine whether a medication, Clonidine can reduce the number of days a baby spends in the hospital and the number of days of medical treatment of withdrawal from Neonatal Abstinence Syndrome (NAS) as compared to Morphine Sulfate (used in routine care) .

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Drug: Clonidine Drug: Morphine Sulfate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double blind prospective trial
Masking: Double (Participant, Care Provider)
Masking Description: The family of the patient (baby), medical provider team and nursing will be masked to the specific arm. Investigator, unless is an active medical provider at the time, and pharmacist will not be masked.
Primary Purpose: Treatment
Official Title: Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clonidine
Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours
Drug: Clonidine
Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours Clonidine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.

Active Comparator: Morphine
Morphine Sulfate at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours
Drug: Morphine Sulfate
Morphine at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours Morphine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.
Other Name: Morphine




Primary Outcome Measures :
  1. Length of stay [ Time Frame: From birth through discharge from the hospital, up to 100 days. ]
    Duration of hospitalization


Secondary Outcome Measures :
  1. Length of treatment [ Time Frame: From initiation of medical treatment through last dose of medication given, up to 100 days ]
    Duration of treatment of Neonatal Abstinence Syndrome with medication/pharmacological treatment from first day initiated until medication has been stopped or patient discharged home



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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Born at Cooper University Hospital
  • Greater than or equal to 35 weeks gestation age
  • Admitted to the NICU or Transitional nursery
  • Mothers admitted to using illicit substances or prescription medications (which can result in withdrawal symptoms) while pregnant and/or had a positive urine drug screen during pregnancy.
  • Babies being started on medication to control withdrawal symptoms of NAS.
  • No congenital anomalies or neurologic condition (i.e. hypoxic-ischemic encephalopathy, seizures, meningitis etc.)

Exclusion Criteria:

  • Premature infants <35 week gestational age
  • Infants with major congenital abnormalities
  • Blood pressure instability
  • Major medical conditions

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): NCT03092011


Contacts
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Contact: Alla Kushnir, MD 856-342-2265 kushnir-alla@cooperhealth.edu
Contact: Rupinder Kaur, MD pinder189@gmail.com

Locations
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United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Alla Kushnir, MD    856-342-2265    kushnir-alla@cooperhealth.edu   
Sponsors and Collaborators
The Cooper Health System
Investigators
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Principal Investigator: Alla Kushnir, MD The Cooper Health System

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Responsible Party: Alla Kushnir, Assistant Professor of Pediatrics, Principal Investigator, The Cooper Health System
ClinicalTrials.gov Identifier: NCT03092011     History of Changes
Other Study ID Numbers: 16-144
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Clonidine
Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action