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    Clinical Trial Results:
    Dexmedetomidine pharmacokinetics-pharmacodynamics in mechanically ventilated neonates with single-organ respiratory failure (NEODEX)

    Summary
    EudraCT number
    		 2010-023155-28
    Trial protocol
    		 BE  
    Global end of trial date
    22 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2024
    First version publication date
    08 Sep 2024
    Other versions
    Summary report(s)
    		 Article

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2010/006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hostital, 32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hostital, 32 93320500, hiruz.ctu@uzgent.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - what are the pharmacokinetic parameters (distribution volume, distribution half-life, terminal half-life, context-sensitive half-life, clearance) of dexmedetomidine infusion in mechanically ventilated neonates with single-organ respiratory failure? - do size, age (postmenstrual, postconceptional, postnatal), co-medication, severity of illness, infusion length (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? - knowledge of the pharmacokinetic parameters of dexmedetomidine and their covariates will allow targeted dosing in this population
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 52 patients were screened in the period from 02-08-2011 till 17-09-2016. 35 patients were included, 34 patients were included and completed the trial. End of trial notification was dated 20-04-2017 (last patient last visit) and submitted to EC and CA 19-04-2017. Only an evaluation of the 6 patients included in the pilot trial has been done.

    Pre-assignment
    Screening details
    		 Inclusion Criteria: patient age less than 1 month (Male/Female) (step-down strategy for age) first included patients (n=30): postmenstrual age >= 34 weeks (near-term neonates) following included patients (n=30) : postmenstrual age >= 25 weeks and < 34 weeks (preterm neonates) patients with single-organ respiratory failure in need for analgo

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Baseline arm
    Arm description
    		 -
    Arm type
    		 Baseline arm

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    dexmedetomidine
    Investigational medicinal product code
    CAS 113775476
    Other name
    Precedex 100μg/ml
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dexmedetomidine 2 ml ampoule containing 200 mcg (100 mcg/ml) dexmedetomidine for dilution with 0,9 % sodium chloride injection.

    Number of subjects in period 1
    		Baseline arm Treatment arm
    Started
    6
    6
    Completed
    6
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline arm
    Reporting group description
    		 -

    Reporting group title
    Treatment arm
    Reporting group description
    		 -

    Reporting group values
    		 Baseline arm Treatment arm Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Postmenstrual age
    Units: weeks
        arithmetic mean (full range (min-max))
    		 39 (34 to 44) 39 (34 to 44) -
    Gender categorical
    Units: Subjects
        Female
    		 3 3 3
        Male
    		 3 3 3
    Reason for admission
    Units: Subjects
        respiratory distress syndrome
    		 3 3 3
        hernia diaphragmatica
    		 1 1 1
        oesophageal atresia repair
    		 1 1 1
        respiratory syncytial virus
    		 1 1 1
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    		 3.18 (2.25 to 4.1) 3.18 (2.25 to 4.1) -

    End points

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    End points reporting groups
    Reporting group title
    Baseline arm
    Reporting group description
    		 -

    Reporting group title
    Treatment arm
    Reporting group description
    		 -

    Primary: Standardised population clearance

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    End point title
    		 Standardised population clearance
    End point description
    End point type
    Primary
    End point timeframe
    Overall trial
    End point values
    		 Baseline arm Treatment arm
    Number of subjects analysed
    6
    6
    Units: L/h
        number (not applicable)
    42.1
    42.1
    Statistical analysis title
    		 standardised population clearance
    Statistical analysis description
    See article in attachment
    Comparison groups
    Baseline arm v Treatment arm
    Number of subjects included in analysis
    12
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 see attachment
    Confidence interval
         level
    		 95%
    Notes
    [1] - See article in attachment
    [2] - See article in attachment

    Secondary: standardised population central volume

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    End point title
    		 standardised population central volume [3]
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See article in attachment
    End point values
    		 Treatment arm
    Number of subjects analysed
    6
    Units: Liter
        number (not applicable)
    80.4
    No statistical analyses for this end point

    Secondary: standardised population inter-compartmental clearance

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    End point title
    		 standardised population inter-compartmental clearance [4]
    End point description
    End point type
    Secondary
    End point timeframe
    Overall study
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See article in attachment
    End point values
    		 Treatment arm
    Number of subjects analysed
    6
    Units: L/h
        number (not applicable)
    12.5
    No statistical analyses for this end point

    Secondary: standardised population peripheral volume

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    End point title
    		 standardised population peripheral volume [5]
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See article in attachment
    End point values
    		 Treatment arm
    Number of subjects analysed
    6
    Units: Liter
        number (not applicable)
    142
    No statistical analyses for this end point

    Secondary: maturation half-life

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    End point title
    		 maturation half-life [6]
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: See article in attachment
    End point values
    		 Treatment arm
    Number of subjects analysed
    6
    Units: week
        number (not applicable)
    36.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Baseline arm
    Reporting group description
    		 -

    Reporting group title
    Treatment arm
    Reporting group description
    		 -

    Serious adverse events
    		 Baseline arm Treatment arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Baseline arm Treatment arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    Cardiac disorders
    Bradychardia
    Additional description: mild
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Feb 2012
    Amendment 5 Description of the substantial amendment: After analysis of the blood concentrations of dexmedetomidin, there was no lower clearing identified, compared to the non-cardiosurgical subpopulation (n = 18). Therefore, the investigators wish to keep the identical dosing regime for the non-surgical patient population. Secondly, they wish to have the possibility to increase the infusion rate of the study medication once, to lean closer to the clinical practice of analgosedation. This because retrospective analysis of the research population showed a need of rescue medication (fentanyl) in > 50 % of the study patients.
    10 Feb 2015
    Amendment 9 Reasons for the substantial amendment: Admission of patients after cardiac surgery.
    25 Aug 2015
    Amendment 10 Reason for the substantial amendment: change of dosing regime

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31312867
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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