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    Clinical Trial Results:
    Efficacy of Gaviscon in the treatment of gastroesophageal reflux in preterm newborns

    Summary
    EudraCT number
    		 2008-001526-13
    Trial protocol
    		 IT  
    Global end of trial date
    31 Dec 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2022
    First version publication date
    28 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    23/2008/O/Sper
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS AOU Bologna
    Sponsor organisation address
    Via Albertoni, 15, Bologna, Italy, 40138
    Public contact
    Dr. Luigi Corvaglia, IRCCS AOU Bologna, +39 2143691, luigi.corvaglia@unibo.it
    Scientific contact
    Dr. Luigi Corvaglia, IRCCS AOU Bologna, +39 2143691, luigi.corvaglia@unibo.it
    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 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of sodium alginate in reducing of gastroesophageal reflux (GER) episodes and of apnoeas related to GER in preterm infants.
    Protection of trial subjects
    Written informed parental⁄guardian consent
    Background therapy
    		 For preterm infants with symptomatic GER, a stepwise therapeutical approach, mainly based on conservative interventions (i.e. body positioning 3) is the first line therapeutic choice.
    Evidence for comparator
    		 Antireflux medications, such as histamine-2 receptor (H2) blockers, are commonly used in preterm infants during hospital stay and also after discharge. However, clinical studies demonstrate that these drugs increase the risk of necrotizing enterocolitis in very-low birth-weight infants and may increase the risk of sepsis. 5 Furthermore, prokinetic drugs such as metoclopramide, have shown to cause serious side effects such as irritability, dystonic reactions, drowsiness, oculogyric crisis, emesis and apnoea in infants.
    Actual start date of recruitment
    01 Sep 2007
    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
    Italy: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    32
    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 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 September 2007-November 2009, Neonatal Intensive Care Unit.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 32
    Intermediate milestone: Number of subjects
    Evaluation of GER: 32
    Number of subjects completed
    		 32

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

    Arms
    Arm title
    		 Full study population
    Arm description
    		 Cross-over trial. Each patient underwent a 24 h, continuous and simultaneous measurement of intra-oesophageal pH and multichannel intraluminal electrical impedance (pH-MII – Sandhill Scientific Inc., Highland Ranch, CO, USA), during which the baby was fed eight times, every 3 hours. Sodium alginate (Gaviscon Reckitt Benckiser Healthcare, Hull, UK) was given four times at alternate meals; these meals were defined as ‘drug-given’ (DG) meals, whereas the remaining four were defined as ‘drug-free’ (DF) meals. The order of meals was predetermined: specifically, the 2nd, 4th, 6th and 8th meals were DG, whereas the remaining were DF.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sodium alginate (Gaviscon Reckitt Benckiser Healthcare, Hull, UK)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    0.25 mL/Kg per dose at alternate meal (the 2nd, 4th, 6th and 8th in 24 hours), every 6 hours.

    Number of subjects in period 1
    		Full study population
    Started
    32
    Completed
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 32 32
    Age categorical
    Units: Subjects
        Preterm newborn-gestational age < 37 wk
    		 32 32
    Age continuous
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    		 35 (34 to 36) -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 12 12
    Gestational age at birth
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    		 30 (27 to 31) -
    Birthweight
    Units: grams
        median (inter-quartile range (Q1-Q3))
    		 1098 (902 to 1450) -
    Postnatal age
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    		 35 (34 to 36) -
    Wight
    Units: grams
        median (inter-quartile range (Q1-Q3))
    		 1680 (1485 to 1930) -
    Subject analysis sets

    Subject analysis set title
    Drug-given meals
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Thirty-two (twelve male) preterm infants with a median gestational age of 30 weeks [interquartile range (IQR), 27–31 weeks] and a median birth weight of 1098 g (IQR, 902–1450 g), studied at a median postnatal age of 35 weeks (IQR, 34–36 weeks) and a median weight of 1680 g (IQR, 1485–1930 g) as they had GER symptoms (frequent regurgitations and postprandial desaturations).

    Subject analysis set title
    Drug-free meals
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Thirty-two (twelve male) preterm infants with a median gestational age of 30 weeks [interquartile range (IQR), 27–31 weeks] and a median birth weight of 1098 g (IQR, 902–1450 g), studied at a median postnatal age of 35 weeks (IQR, 34–36 weeks) and a median weight of 1680 g (IQR, 1485–1930 g) as they had GER symptoms (frequent regurgitations and postprandial desaturations).

    Subject analysis sets values
    		 Drug-given meals Drug-free meals
    Number of subjects
    32
    32
    Age categorical
    Units: Subjects
        Preterm newborn-gestational age < 37 wk
    32
    32
    Age continuous
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    35 (34 to 36)
    35 (34 to 36)
    Gender categorical
    Units: Subjects
        Female
    20
    20
        Male
    12
    12
    Gestational age at birth
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    30 (27 to 31)
    30 (27 to 31)
    Birthweight
    Units: grams
        median (inter-quartile range (Q1-Q3))
    1098 (902 to 1450)
    1098 (902 to 1450)
    Postnatal age
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    35 (34 to 36)
    35 (34 to 36)
    Wight
    Units: grams
        median (inter-quartile range (Q1-Q3))
    1680 (1485 to 1930)
    1680 (1485 to 1930)

    End points

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    End points reporting groups
    Reporting group title
    Full study population
    Reporting group description
    		 Cross-over trial. Each patient underwent a 24 h, continuous and simultaneous measurement of intra-oesophageal pH and multichannel intraluminal electrical impedance (pH-MII – Sandhill Scientific Inc., Highland Ranch, CO, USA), during which the baby was fed eight times, every 3 hours. Sodium alginate (Gaviscon Reckitt Benckiser Healthcare, Hull, UK) was given four times at alternate meals; these meals were defined as ‘drug-given’ (DG) meals, whereas the remaining four were defined as ‘drug-free’ (DF) meals. The order of meals was predetermined: specifically, the 2nd, 4th, 6th and 8th meals were DG, whereas the remaining were DF.

    Subject analysis set title
    Drug-given meals
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Thirty-two (twelve male) preterm infants with a median gestational age of 30 weeks [interquartile range (IQR), 27–31 weeks] and a median birth weight of 1098 g (IQR, 902–1450 g), studied at a median postnatal age of 35 weeks (IQR, 34–36 weeks) and a median weight of 1680 g (IQR, 1485–1930 g) as they had GER symptoms (frequent regurgitations and postprandial desaturations).

    Subject analysis set title
    Drug-free meals
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Thirty-two (twelve male) preterm infants with a median gestational age of 30 weeks [interquartile range (IQR), 27–31 weeks] and a median birth weight of 1098 g (IQR, 902–1450 g), studied at a median postnatal age of 35 weeks (IQR, 34–36 weeks) and a median weight of 1680 g (IQR, 1485–1930 g) as they had GER symptoms (frequent regurgitations and postprandial desaturations).

    Primary: GER features

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    End point title
    		 GER features
    End point description
    End point type
    Primary
    End point timeframe
    24 hours
    End point values
    		 Drug-given meals Drug-free meals
    Number of subjects analysed
    32
    32
    Units: Number
    median (inter-quartile range (Q1-Q3))
        total GER episodes
    49 (28.50 to 67.00)
    58.8 (33.50 to 75.75)
        NaMII- GER
    19 (10.00 to 32.75)
    18.50 (8.50 to 33.75)
        GER reaching proximal oesophagus
    5.50 (4.00 to 9.00)
    7.50 (3.00 to 12.00)
        pH-GER
    17 (6.00 to 29.75)
    29 (13.50 to 44.50)
        aMII-GER
    4 (2.00 to 8.25)
    6 (2.25 to 11.75)
    Statistical analysis title
    		 GER features
    Comparison groups
    Drug-given meals v Drug-free meals
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Total apnoea episodes

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    End point title
    		 Total apnoea episodes
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Drug-given meals Drug-free meals
    Number of subjects analysed
    32
    32
    Units: Number
        median (full range (min-max))
    9.5 (0 to 35)
    9.5 (0 to 44)
    Statistical analysis title
    		 Total apnoea episodes
    Comparison groups
    Drug-given meals v Drug-free meals
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Apnoea related to GER

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    End point title
    		 Apnoea related to GER
    End point description
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Drug-given meals Drug-free meals
    Number of subjects analysed
    32
    32
    Units: number/min
        median (full range (min-max))
    0 (0 to 0.67)
    0 (0 to 0.47)
    Statistical analysis title
    		 Apnoea related to GER
    Comparison groups
    Drug-given meals v Drug-free meals
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    September 2007-December 2010
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Overall study population
    Reporting group description
    		 Adverse events related to Gaviscon 1 mL/Kg

    Serious adverse events
    		 Overall study population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.3%
    Non-serious adverse events
    		 Overall study population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    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: Gaviscon is widely used among pediatric populations and adverse reactions caused by Gaviscon are very rare. For these reasons, non-serious adverse events were not observed in a small group of 32 experimental subjects.

    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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