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Trial record 21 of 331 for:    clonidine

Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome

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ClinicalTrials.gov Identifier: NCT03762317
Recruitment Status : Suspended (IND exemption pending)
First Posted : December 3, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
kunal gupta, Hennepin County Medical Center, Minneapolis

Brief Summary:
This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the management of term and near term infants with neonatal abstinence syndrome (NAS)

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

Detailed Description:

Neonatal abstinence syndrome (NAS) is an emerging epidemic and has lead to a tremendous increase in cost of medical care. Opioids are the mainstay of treatment for NAS although there are concerns about possible short-term and long-term effects including but not limited to adverse neurodevelopmental outcomes. Other drugs such as clonidine, phenobarbitone, methadone and buprenorphine have been evaluated to limit the postnatal exposure to opioids in these infants. Clonidine is an alpha 2 receptor and can lessen withdrawal manifestations. The addition of clonidine at 6 µg/kilogram/day to morphine in the management of NAS has been shown to reduce the duration of pharmacotherapy by about 27% in a previous study.

A recent pilot study reported reduction of treatment duration for NAS with clonidine (12 µg/kilogram/day) monotherapy as compared to morphine monotherapy. The study reported no adverse effects in study subjects at the doses used in the study. The investigators hypothesize that there will be a minimum of 30% reduction in the treatment duration with 12 µg/kilogram/day clonidine used as adjuncts to standard morphine treatment as compared to morphine monotherapy in the management of term and near term infants with NAS


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clonidine as Adjunct to Morphine in the Management of Term and Near Term Infants With Neonatal Abstinence Syndrome
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: clonidine
Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period
Drug: Clonidine
clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine

Placebo Comparator: Placebo
Placebo solution will be given for the duration of the study period
Drug: Placebo
Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine




Primary Outcome Measures :
  1. duration of pharmacotherapy for NAS [ Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days ]
    The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped


Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days ]
    Number of days spent in the hospital

  2. Maximum dose of morphine used [ Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days ]
    The maximum dose of morphine in mg/kg used for symptom control

  3. Cumulative dose of oral morphine over hospital stay [ Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days ]
    The total dose of morphine used through study period in mg/kg

  4. Total number of episodes of heart rate variability (heart beats/min) [ Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days ]
    No of episodes of bradycardia (HR< 60/min for a min of 20 seconds and not associated with apnea or signs of reflux such as emesis, regurgitation of milk into the mouth or nose, arching while feeding, no of episodes of tachycardia (> 200/min) and not related to pain and/or agitation

  5. Total number of episodes of blood pressure (mm of Hg) variability [ Time Frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days ]
    No of episodes of hypotension (Blood pressure < 5th percentile for age) and hypertension (blood pressure > 95th percentile for age)



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Ages Eligible for Study:   36 Weeks to 45 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Requiring neonatal intensive care unit (NICU) admission for management of neonatal abstinence syndrome
  • Gestational age greater than or equal to 36 weeks
  • Less than or equal to 48 hours of treatment with morphine for NAS

Exclusion Criteria:

  • Presence of seizures
  • Congenital malformations, genetic syndromes or the presence of TORCH infections
  • Major medical problems
  • Heart rate and/or blood pressure instability

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): NCT03762317


Locations
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United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin County Medical Center, Minneapolis
Investigators
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Principal Investigator: kunal gupta Hennepin County Medical Center, Minneapolis
Principal Investigator: vinay sharma Hennepin County Medical Center, Minneapolis

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Responsible Party: kunal gupta, Assistant Professor, Hennepin County Medical Center, Minneapolis
ClinicalTrials.gov Identifier: NCT03762317     History of Changes
Other Study ID Numbers: NAS
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 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