NL-OMON40616已完成4 期
Prevention of renal and bladder damage in children with spina bifida by means of early injections with Botulinum-Toxin-A (Botox): a pilot study. - Early Botox in SB patients.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •The study group exists of newborns with MMC who are treated with the standard treatment (CIC and anticholinergics). The minimal age at inclusion is 3 months. This is because of the minimal diameter of the urethra which is necessary for cystoscopy.;The historical control group exists of MMC patients who have not been treated with Botox and who were born between 1998 and 2008.
排除标准
- •The exclusion criteria for the study group are:
- •- Patients with swallowing or breathing problems for which medical treatment is or was necessary.
- •- Muscle diseases such as myasthenia gravis, amyotrophic lateral sclerosis or the Syndrome of Eaton-Lambert.;For the historical group the database of (parents of) patients who object against the use of their medical records for research purposes.
研究者
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