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Trial record 31 of 326 for:    clonidine

Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants (SANNI 1)

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ClinicalTrials.gov Identifier: NCT03177980
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
Lund University
Karolinska Institutet
Helsinki University Central Hospital
Great Ormond Street Hospital for Children NHS Foundation Trust
Örebro University, Sweden
The Swedish Research Council
University of Colorado, Denver
University of Tartu
Information provided by (Responsible Party):
Region Skane

Brief Summary:
A prospective pharmacokinetic (PK), pharmacodynamic (PD) and pharmacogenetic (PG) observation study, including the PK/PD/PG relationship, in fentanyl and clonidine administered for analgesia and sedation to term newborn asphyxiated infants receiving hypothermic treatment in the NICU.

Condition or disease Intervention/treatment
Asphyxia Neonatorum Drug: Fentanyl Drug: Fentanyl and clonidine

Detailed Description:

All patients that are admitted to the study neonatal intensive care units (NICUs) for hypothermic treatment due to perinatal asphyxia are potential study patients, and their parents will be asked for consent.

The patient will be treated according to clinical guidelines and will be included in the study if in need for fentanyl and clonidine according to clinical judgment (HIE and pain scores) and as decided by the responsible clinical doctor. The dosing and administration of the drugs will be implemented according to an algorithm based on pain scoring results.

Apart from extra blood sampling, the bedside monitoring, investigations (electroencephalography (EEG), echocardiography (ECG), ultrasound of the brain and magnetic resonance imaging, (MRI)) and follow-up (neurologic examination) are the same as for all infants receiving hypothermia according to national and international guidelines. A brief standardised pain stimulation will be performed as part of the pain and stress assessment.

In total 50 infants will be included.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fentanyl and Clonidine for Analgesia During Hypothermia in Term Asphyxiated Infants - a Prospective Pharmacokinetic/Pharmacodynamic/Pharmacogenetic Observational Study. Cohort 1 in The SANNI Project.
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort Intervention/treatment
Fentanyl
All infants in need of analgesia according to an algorithm based on pain assessment results will receive fentanyl as the first analgesic drug.
Drug: Fentanyl
The dosing and administration of fentanyl will serve as the first drug intervention in infants in need of analgesia according to an algorithm based on pain scoring results.

Fentanyl and Clonidine
Infants in need of further analgesia according to an algorithm based on pain assessment results will receive fentanyl and clonidine as the analgesic drugs.
Drug: Fentanyl and clonidine
In infants in need of further analgesia clonidine will be administered as an add on drug according to an algorithm based on pain scoring results.




Primary Outcome Measures :
  1. Pharmacokinetics (PK) of fentanyl and clonidine [ Time Frame: Repeated blood samples over a total of 4 - 7 days] ]
    Analysed with NONMEM (Non-linear Mixed Effect Modelling) populationbased PK statistics

  2. Neurophysiologic response; by single cortical events and their dynamics in relation to PK [ Time Frame: From admission to the department until 4- 72 h after reaching normothermia.] ]
    Analyse of single cortical events and their dynamics based on burst detection and measuring features of individual bursts as well as their mass statistical behaviour over time.

  3. Neurophysiologic response; longer term brain function in relation to PK [ Time Frame: From admission to the department until 4- 72 h after reaching normothermia ]
    Assessment of longer term brain function using measures of long range correlation and brain activity cycling.

  4. Neurophysiologic response; global brain network function in relation to PK [ Time Frame: From admission to the department until 4- 72 h after reaching normothermia ]
    Assessment of global brain network function will be based on Activation Synchrony Index.


Secondary Outcome Measures :
  1. Change in/association between physiological parameters (heart rate, blood pressure, peripheral oxygen saturation and NIRS (near-infrared reflectance spectroscopy near-infrared spectroscopy) parameters) in relation to PK parameters [ Time Frame: From admission to the department until 4- 72 h after reaching normothermia. ]
  2. Change in pain responses as measured by pain assessment score for continuous pain/stress (ALPS-Neo and Comfort Neo) in relation to PK [ Time Frame: From admission to the department until 4- 72 h after reaching normothermia. ]
  3. Procedural pain response at a short standardized pain stimulation; as assessed with change in galvanic skin response, change in serum-cortisol and scored by a procedural pain assessment scale (PIPP-R) in relation to PK. [ Time Frame: Once during stable treatment with hypothermia and 6 hours of unchanged medication ]
  4. Pharmacogenetic profile in relation to PK and PD results; how PK/PD phenotypes depend on pharmacogenetic (PG) profiles. [ Time Frame: One blood sample during study ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   36 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Term asphyxiated infants admitted to the NICU for hypothermic treatment according to national and international guidelines and in need for analgesia according to pain assessment scales.
Criteria

Inclusion Criteria:

  • Term infants (≥ gw 36+0) who, according to national guidelines (6), will receive hypothermic treatment following perinatal asphyxia, and are in need for analgesic or sedative medication according to clinical judgment based on Thomsons score and ALPS-Neo.
  • Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling
  • Informed and written parental consent.

Exclusion Criteria:

  • Atrioventricular (AV)- block I-III or heart rate < 70 .
  • Serious coronary heart disease with need for postnatal surgery
  • Mean arterial blood pressure <35 mmHg despite adequate treatment.

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): NCT03177980


Contacts
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Contact: Elisabeth Norman, MD +46 705594340 elisabeth.norman@med.lu.se

Locations
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Sweden
Skåne Uniersity Hospital Recruiting
Lund, Sweden, 221 85
Contact: Elisabeth Norman, MD, PhD    +46 705594340    elisabeth.norman@med.lu.se   
Principal Investigator: Elisabeth Norman, MD, PhD         
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden, 171 76
Contact: Boubou Hallberg, MD, PhD    + 46 70 002 10 10    boubou.hallberg@ki.se   
Principal Investigator: Boubou Hallberg, MD, PhD         
Sponsors and Collaborators
Region Skane
Lund University
Karolinska Institutet
Helsinki University Central Hospital
Great Ormond Street Hospital for Children NHS Foundation Trust
Örebro University, Sweden
The Swedish Research Council
University of Colorado, Denver
University of Tartu
Investigators
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Principal Investigator: Elisabeth Norman, MD Region Skane and Lunds University

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03177980     History of Changes
Other Study ID Numbers: 2015-002470-20
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Region Skane:
clonidine
Term infants
Analgesia
fentanyl
pharmacokinetics
sedation
pharmacodynamics
neurophysiology
pharmacogenetics
asphyxia
hypothermia
Additional relevant MeSH terms:
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Clonidine
Asphyxia Neonatorum
Hypothermia
Asphyxia
Body Temperature Changes
Signs and Symptoms
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents