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Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA) (OVB in EA)

Primary Purpose

Esophageal Atresia, Anastomotic Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Budesonide Oral
Placebos
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Esophageal Atresia

Eligibility Criteria

1 Month - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged > 1 month to 3 years
  • Operated for an esophageal atresia of all types except pure TEF.

  • Presence of an anastomotic stricture defined according to experts recommendations :

    • a relative esophageal narrowing at the level of the anastomosis,
    • demonstrated by a contrast study and/or an endoscopy
    • with significant functional impairment and associated symptoms requiring dilation.
    • Symptoms include: feeding or swallowing difficulties, coughing and choking during feeds, food impaction, regurgitation/vomiting of undigested food, drooling. In very young patients: apnea and food refusal.
  • Receiving an ongoing treatment by PPI 1 to 2 mg/kg die
  • Informed parental consent

Exclusion Criteria:

  • Known immune deficiency
  • Acute respiratory or intestinal infection
  • Severe respiratory, cardiac or neurological condition precluding OVB or placebo swallowing
  • Child fed exclusively via nasogastric tube or gastrostomy
  • Absence of parental consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Budesonide

    Placebo

    Arm Description

    Oral viscous budesonide will be given in apple sauce according to body weight at inclusion: < 10 kg: 250 mcg BID in 5 ml apple sauce 10 kg to <15 kg: 500 mcg BID in 5 ml apple sauce >15 kg: 1000 mcg BID in 5 ml apple sauce

    Placebo: 5 ml apple sauce BID plus 1 mL saline

    Outcomes

    Primary Outcome Measures

    number of dilations needed after randomization (beginning of treatment)
    number of dilations needed after randomization (beginning of treatment)

    Secondary Outcome Measures

    Number of patients needing dilation after randomization (beginning of treatment)
    Number of patients needing dilation after randomization (beginning of treatment)
    Number of patients needing more than 3 dilations after randomization
    Number of patients needing more than 3 dilations after randomization
    Mean time to further dilation
    Mean time to further dilation
    Number of patients treated with an adjuvant therapy
    Number of patients treated with an adjuvant therapy
    Ability to tolerate normal food for age
    Ability to tolerate normal food for age
    Dysphagia score
    Dysphagia score
    Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
    Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
    Side effects/Adverse events
    Side effects/Adverse events

    Full Information

    First Posted
    June 14, 2019
    Last Updated
    June 24, 2019
    Sponsor
    St. Justine's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03999008
    Brief Title
    Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)
    Acronym
    OVB in EA
    Official Title
    A Multicentre, Prospective, Randomized, Placebo Controlled, Double-blinded Study to Demonstrate Potential and Beneficial Effects of Oral Viscous Budesonide (OVB) in the Prevention of Recurrence of Anastomotic Stricture in Children Operated on for Esophageal Atresia With Recurrent Anastomotic Strictures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2022 (Anticipated)
    Study Completion Date
    June 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Justine's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study is to perform a multicentre, prospective, randomized, placebo controlled, double-blinded study to demonstrate the potential and beneficial effects of OVB in the prevention of recurrence of anastomotic stricture in children operated for esophageal atresia with an anastomotic stricture.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Atresia, Anastomotic Stenosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Budesonide
    Arm Type
    Active Comparator
    Arm Description
    Oral viscous budesonide will be given in apple sauce according to body weight at inclusion: < 10 kg: 250 mcg BID in 5 ml apple sauce 10 kg to <15 kg: 500 mcg BID in 5 ml apple sauce >15 kg: 1000 mcg BID in 5 ml apple sauce
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo: 5 ml apple sauce BID plus 1 mL saline
    Intervention Type
    Drug
    Intervention Name(s)
    Budesonide Oral
    Intervention Description
    The subjects will be included at time of the first dilation for an anastomotic stricture. Basal physical exam and clinical evaluation (weight and height, dysphagia score, gastroesophageal reflux, feeding problems, respiratory symptoms, other symptoms). Randomization will be conducted by centre. Because long gap esophageal atresia, high tension anastomosis and history of anastomotic leak are reported as risk factors for occurrence of anastomotic strictures, a stratification at randomization will be performed according to these criteria in each centre. OVB or placebo will be given by the parents and started the day of the dilation at the first meal after recovering of the dilation and anesthesia. Parents will be asked to bring the empty caps which will be counted for assessment of compliance.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    Apple Sauce 5 mL+ 1 mL saline
    Primary Outcome Measure Information:
    Title
    number of dilations needed after randomization (beginning of treatment)
    Description
    number of dilations needed after randomization (beginning of treatment)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Number of patients needing dilation after randomization (beginning of treatment)
    Description
    Number of patients needing dilation after randomization (beginning of treatment)
    Time Frame
    12 months
    Title
    Number of patients needing more than 3 dilations after randomization
    Description
    Number of patients needing more than 3 dilations after randomization
    Time Frame
    12 months
    Title
    Mean time to further dilation
    Description
    Mean time to further dilation
    Time Frame
    12 months
    Title
    Number of patients treated with an adjuvant therapy
    Description
    Number of patients treated with an adjuvant therapy
    Time Frame
    12 months
    Title
    Ability to tolerate normal food for age
    Description
    Ability to tolerate normal food for age
    Time Frame
    12 months
    Title
    Dysphagia score
    Description
    Dysphagia score
    Time Frame
    12 months
    Title
    Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
    Description
    Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
    Time Frame
    12 months
    Title
    Side effects/Adverse events
    Description
    Side effects/Adverse events
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children aged > 1 month to 3 years Operated for an esophageal atresia of all types except pure TEF. Presence of an anastomotic stricture defined according to experts recommendations : a relative esophageal narrowing at the level of the anastomosis, demonstrated by a contrast study and/or an endoscopy with significant functional impairment and associated symptoms requiring dilation. Symptoms include: feeding or swallowing difficulties, coughing and choking during feeds, food impaction, regurgitation/vomiting of undigested food, drooling. In very young patients: apnea and food refusal. Receiving an ongoing treatment by PPI 1 to 2 mg/kg die Informed parental consent Exclusion Criteria: Known immune deficiency Acute respiratory or intestinal infection Severe respiratory, cardiac or neurological condition precluding OVB or placebo swallowing Child fed exclusively via nasogastric tube or gastrostomy Absence of parental consent

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)

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