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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide | Active Comparator | 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 | Placebo Comparator | Placebo: 5 ml apple sauce BID plus 1 mL saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide Oral | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| number of dilations needed after randomization (beginning of treatment) | number of dilations needed after randomization (beginning of treatment) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients needing dilation after randomization (beginning of treatment) | Number of patients needing dilation after randomization (beginning of treatment) | 12 months |
| Number of patients needing more than 3 dilations after randomization |
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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 :
Receiving an ongoing treatment by PPI 1 to 2 mg/kg die
Informed parental consent
Exclusion Criteria:
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| ID | Term |
|---|---|
| D004933 | Esophageal Atresia |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Placebos | Drug | Apple Sauce 5 mL+ 1 mL saline |
|
Number of patients needing more than 3 dilations after randomization
| 12 months |
| Mean time to further dilation | Mean time to further dilation | 12 months |
| Number of patients treated with an adjuvant therapy | Number of patients treated with an adjuvant therapy | 12 months |
| Ability to tolerate normal food for age | Ability to tolerate normal food for age | 12 months |
| Dysphagia score | Dysphagia score | 12 months |
| 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 | 12 months |
| Side effects/Adverse events | Side effects/Adverse events | 12 months |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |