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    Clinical Trial Results:
    Trial on treatment with inhaled furosemide of preterm and term neonates with transient tachypnoea

    Summary
    EudraCT number
    		 2011-003473-29
    Trial protocol
    		 DE  
    Global end of trial date
    09 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Dec 2020
    First version publication date
    26 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Uni-Koeln-1488
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01407848
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus-Magnus-Platz, Cologne, Germany, 50923
    Public contact
    Klinisches Studienzentrum Pädiatrie, University Hospital Cologne, +49 2214786831, kinderklinik-studiensekretariat@uk-koeln.de
    Scientific contact
    Klinisches Studienzentrum Pädiatrie, University Hospital Cologne, +49 2214786831, kinderklinik-studiensekretariat@uk-koeln.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
    28 Jun 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary endpoint of the study is the reduction of the Silverman score as an indicator of respiratory distress of the infant. Silverman Score is the standard score to describe the degree of respiratory distress of neonate.
    Protection of trial subjects
    The trial was conducted according to Good Clinical Practice guidelines, the applicable local laws, and in accordance with the ethical principles that have their origins in the Declaration of Helsinki. The competent authorities approved the trial as required by national regulations. Regulatory authorities were notified of the trial and amendments as required by national regulations. Given the pilot nature of the trial, no interim analyse and no DMSC is foreseen. An Advisory Committee will be established, whose task will be to objectively discuss the (safety) data collected in the trial at EOT.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Apr 2013
    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
    Germany: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    14
    Newborns (0-27 days)
    6
    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
    		 -

    Pre-assignment
    Screening details
    		 Premature and newborn children with clinical symptoms of a transient tachpnoe (respiratory frequency more than 60/min for premature and more than 50/min for newborn childern) and other in-and exclusion criteria.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Furosemid
    Arm description
    		 Furosemid solution as inhalation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Furosemid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    1ml/kg every 6 hours

    Arm title
    		 NaCl (0.9%)
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    NaCl (0,9%)
    Investigational medicinal product code
    Other name
    Easyflex N Iso NaCl 500ml
    Pharmaceutical forms
    Solution for infusion in administration system
    Routes of administration
    Inhalation use
    Dosage and administration details
    NaCl was used for inhalation ( 1ml/kg)

    Number of subjects in period 1
    		Furosemid NaCl (0.9%)
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Furosemid
    Reporting group description
    		 Furosemid solution as inhalation

    Reporting group title
    NaCl (0.9%)
    Reporting group description
    		 Placebo

    Reporting group values
    		 Furosemid NaCl (0.9%) Total
    Number of subjects
    		 10 10 20
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 36.7 ( 1.4 ) 36.2 ( 1.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 1 7
        Male
    		 4 9 13

    End points

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    End points reporting groups
    Reporting group title
    Furosemid
    Reporting group description
    		 Furosemid solution as inhalation

    Reporting group title
    NaCl (0.9%)
    Reporting group description
    		 Placebo

    Primary: Area unter the Curve (AUC) of Silverman-Score

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    End point title
    		 Area unter the Curve (AUC) of Silverman-Score
    End point description
    AUC Silverman-Score
    End point type
    Primary
    End point timeframe
    26 and 72 hours from baseline
    End point values
    		 Furosemid NaCl (0.9%)
    Number of subjects analysed
    10
    10
    Units: cm²
    arithmetic mean (standard deviation)
        26 hours
    44.1 ( 32.2 )
    54.0 ( 36.4 )
        72 hours
    91.6 ( 85.2 )
    97.2 ( 71.8 )
    Statistical analysis title
    		 AUC Silvermann Score
    Statistical analysis description
    The primary target was the AUC (area under the curve) of the modified Silverman score. The measurements of the first 26 hours and 72 h of treatment were measured linearly interpolated and basedn on this AUC calculated. In case of intubation or premature end of therapy the missing values for 26 or 72 hours were updated by the end of treatment value. The statistical analysis was performed with SAS (V 9.3; t-test, p<0.05). Safety parameters were evaluated descriptively
    Comparison groups
    Furosemid v NaCl (0.9%)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: CPAP

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    End point title
    		 CPAP
    End point description
    End point type
    Secondary
    End point timeframe
    Hours since start of IMP
    End point values
    		 Furosemid NaCl (0.9%)
    Number of subjects analysed
    10
    10
    Units: hours
        arithmetic mean (standard deviation)
    18.6 ( 16.6 )
    25.3 ( 21.9 )
    No statistical analyses for this end point

    Secondary: Intubation

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    End point title
    		 Intubation
    End point description
    Number of intubated patients
    End point type
    Secondary
    End point timeframe
    0h until 72h
    End point values
    		 Furosemid NaCl (0.9%)
    Number of subjects analysed
    10
    10
    Units: Patient
    0
    0
    No statistical analyses for this end point

    Secondary: Sodium

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    End point title
    		 Sodium
    End point description
    End point type
    Secondary
    End point timeframe
    0h-72h
    End point values
    		 Furosemid NaCl (0.9%)
    Number of subjects analysed
    10
    10
    Units: mmol/L
    arithmetic mean (standard deviation)
        0 hours
    136 ( 4.4 )
    137.1 ( 1.8 )
        24 hours
    141.6 ( 5.6 )
    140.4 ( 2.5 )
        48 hours
    146.0 ( 3.5 )
    142.0 ( 4.0 )
        72 hours
    146 ( 5.7 )
    142.0 ( 0.0 )
    No statistical analyses for this end point

    Secondary: Potassium

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    End point title
    		 Potassium
    End point description
    End point type
    Secondary
    End point timeframe
    0h-72h
    End point values
    		 Furosemid NaCl (0.9%)
    Number of subjects analysed
    10
    10
    Units: mmol/L
    arithmetic mean (standard deviation)
        0 hours
    5.4 ( 0.8 )
    5.8 ( 0.6 )
        24 hours
    4.7 ( 0.6 )
    4.6 ( 0.7 )
        48 hours
    4.2 ( 0.5 )
    4.0 ( 0.5 )
        72 hours
    4.3 ( 0.1 )
    4.2 ( 0.0 )
    No statistical analyses for this end point

    Secondary: pH

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    End point title
    		 pH
    End point description
    End point type
    Secondary
    End point timeframe
    0h-72h
    End point values
    		 Furosemid NaCl (0.9%)
    Number of subjects analysed
    10
    10
    Units: negative of the base log. H+ activity
    arithmetic mean (standard deviation)
        0 hours
    7.3 ( 0.1 )
    7.3 ( 0.1 )
        24 hours
    7.3 ( 0.1 )
    7.3 ( 0.0 )
        48 hours
    7.4 ( 0.0 )
    7.3 ( 0.0 )
        72 hours
    7.4 ( 0.0 )
    7.4 ( 0.0 )
    No statistical analyses for this end point

    Secondary: Area under curve (AUC) additional FiO2

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    End point title
    		 Area under curve (AUC) additional FiO2
    End point description
    End point type
    Secondary
    End point timeframe
    26 and 72 Hours from baseline
    End point values
    		 Furosemid NaCl (0.9%)
    Number of subjects analysed
    10
    10
    Units: cm2
    arithmetic mean (standard deviation)
        26 hours
    0.5 ( 1.3 )
    1.5 ( 2.7 )
        72 hours
    0.7 ( 1.8 )
    2.7 ( 5.7 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from signature of informed consent form.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Furosemid
    Reporting group description
    		 -

    Reporting group title
    NaCl (0.9%)
    Reporting group description
    		 -

    Serious adverse events
    		 Furosemid NaCl (0.9%)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Furosemid NaCl (0.9%)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    Gastrointestinal disorders
    Gastric haemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0

    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.
    None reported
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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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