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    Clinical Trial Results:
    Effect of plasma volume expansion with hydroxy-ethyl-starch (HES) 130/0.4 or crystalloids on interstitial fluid accumulation and blood pressure in newborn infants with arterial hypotension

    Summary
    EudraCT number
    		 2004-002096-16
    Trial protocol
    		 AT  
    Global end of trial date
    31 Dec 2005

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Aug 2022
    First version publication date
    10 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    01/04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    OA Dr. med. Salvador Navarro-Psihas
, Bischof-Altmann-Str. 9, 94032 Passau, Kinderklinik Dritter Orden Passau , +49 0851 / 72 05 310, salvador.navarro-psihas@kinderklinik-passau.de
    Scientific contact
    OA Dr. med. Salvador Navarro-Psihas
, Bischof-Altmann-Str. 9, 94032 Passau, Kinderklinik Dritter Orden Passau , +49 0851 / 72 05 310, salvador.navarro-psihas@kinderklinik-passau.de
    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
    31 Dec 2005
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2005
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    We investigate in newborns (e.g. term or preterm infants of less than 44 weeks postmenstrual age) with arterial hypotension, whether plasma volume expansion by HES 130/0.4 (Voluven) leads to less fluid loss into the interstitial space and increases the blood pressure more effectively and permanently than the administration of crystalloid solutions .
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 May 2005
    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
    Austria: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    99999
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No patients were recruited for this trial. "99999" is a value for 0 participants.

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hydroxy-Ethyl-Starch 130/0,4
    Investigational medicinal product code
    Other name
    Voluven
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    N/A

    Investigational medicinal product name
    Isotonic electrolyte solution
    Investigational medicinal product code
    Other name
    Ringer Lactate
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    N/A

    Number of subjects in period 1
    		Treatment
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 No patients were recruited for this trial. "99999" is a value for 0 participants.

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 99999 99999
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 99999 99999
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: days
        arithmetic mean (standard deviation)
    		 0 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Primary: Hydroxy-Ethyl-Starch 130/0,4/ Isotonic electrolyte solution

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    End point title
    		 Hydroxy-Ethyl-Starch 130/0,4/ Isotonic electrolyte solution [1]
    End point description
    End point type
    Primary
    End point timeframe
    N/A
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No patients were enrolled in this trial, therefore no statistical analysis was performed.
    End point values
    		 Treatment
    Number of subjects analysed
    99999 [2]
    Units: N/A
        number (not applicable)
    1
    Notes
    [2] - "99999" is a value for 0 participants
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    24.05.2005-31.12.2005
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    2.0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No patients were enrolled in this trial, therefore no AEs or SAEs were observed.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    No patients were enrolled in this trial. "99999" is a value for 0 participants.
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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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