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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- number of dilations needed after randomization (beginning of treatment)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Budesonide
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
干预措施: Budesonide Oral (Drug)
Placebo
Placebo: 5 ml apple sauce BID plus 1 mL saline
干预措施: Placebos (Drug)
结局指标
主要结局
number of dilations needed after randomization (beginning of treatment)
时间窗: 12 months
number of dilations needed after randomization (beginning of treatment)
次要结局
- Mean time to further dilation(12 months)
- Number of patients needing more than 3 dilations after randomization(12 months)
- Ability to tolerate normal food for age(12 months)
- Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age(12 months)
- Number of patients needing dilation after randomization (beginning of treatment)(12 months)
- Dysphagia score(12 months)
- Number of patients treated with an adjuvant therapy(12 months)
- Side effects/Adverse events(12 months)
研究者
Christophe Faure
Principal Investigator
St. Justine's Hospital