Primary Vesicoureteral Reflux in Children

儿童原发性膀胱输尿管反流

• 批准号: 7243353
• 负责人: TEJ K MATTOO
• 金额: $ 48.41万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7243353
• 关键词: 2 year old; Abdomen; Age; Age-Years; American; Antibiotic Prophylaxis; Antibiotic Resistance; Antibiotics; Anxiety; Biological Markers; Bladder; Blood; Child; Childhood; Clinical; Constipation; Daily; Development; Diagnosis; Double-Blind Method; Endoscopy; Female; Frequencies; Glomerular Filtration Rate; High Blood Pressure; Hypertension; Image; Injection of therapeutic agent; Injury; Iohexol; Joints; Kidney; Kidney Transplantation; Measurement; Medical; Nephrology; Newly Diagnosed; Operative Surgical Procedures; Outcome; Pain; Patients; Pediatrics; Placebos; Prevalence; Prophylactic treatment; Radiology Specialty; Randomized; Rate; Recruitment Activity; Recurrence; Research Personnel; Resolution; Risk; Risk Factors; Score; Severities; Study Subject; Surgical Replantation; Symptoms; Testing; Urinary tract infection; Urination; Urine; Urologist; Vesico-Ureteral Reflux; Visit; clinically relevant; deflux; male; placebo controlled study; prevent; programs; renal scarring; transplant registry

DESCRIPTION (provided by applicant): Primary vesicoureteral reflux (VUR) is a common problem, occuring [sic] in 8-50% of children with urinary tract infection (UTI). It has the potential for causing irreparable renal damage, particularly [sic] in younger children. Despite the widespread use of antibiotic prophylaxis in children with VUR, there are no placebo-controlled studies demonstrating its clinical benefit in preventing renal injury. The main aim of our proposed double blind, placebo-controled [sic] study is to test the hypothesis that prolonged antibiotic prophylaxis in children > 2 years old with grade I-IV VUR is unnecessary. Our study, which is a joint effort of 28 Pediatric Nephrologists and 9 Pediatric Urologists from 28 centers affiliated with the North American Pediatrics Renal Transplant Registry (NAPRTCS) and the Midwest Pediatric Nephrology Consortium (MWPNC) will test this hypothesis by recruiting 120 children up to the age of 10 years with newly diagnosed grades I-IV VUR. We propose using antibiotic prophylaxis in all eligible subjects up to the age of 2 years or a minimum of 6 months from the diagnosis of VUR (whichever comes later) and subsequently randomizing them into prophylaxis and placebo groups. Children >2 years old will be randomized directly at study entry into prophylaxis and placebo groups. Followup will include biannual clinc [sic] visits; yearly renal imaging, blood and urine tests, and assessment for dysfunctional voiding (DV) and constipation; and the measurement of glomerular filtration rate by iohexol clearance. By randomization, we will test our first hypothesis that antibiotic prophylaxis after age 2 years does not decrease the frequency of UTI, reduce the risk of renal scarring, or enhance resolution of VUR. By using objecitve [sic] scoring for DV and constipation, we will test our second hypothesis that their presence delays resolution of VUR, and increases the frequency of UTI and renal scarring, irrespective of long-term antibiotic prophylaxis. Patients who fail medical management will be randomized into Delfux or surgical reimplantation groups to test our third hypothesis that the two treatments do not differ in cure rate, recurrence rate of UTI, or risk of renal scarring. Vesicoureteral reflux, the abnormal flow of urine from the bladder into the kidneys, is common in children and may cause kidney damage and high blood pressure. Current treatment uses daily antibiotics for years, but this may not be necessary and may cause some harm, inlcuding [sic] resistance to antibiotics, requiring children to have expensive and painful radiology tests and surgical procedures, and causing parental anxiety. This study will determine if long-term antibiotics are necessary in children with VUR

描述（由申请人提供）： 原发性膀胱输尿管反流 (VUR) 是一种常见问题，8-50% 的尿路感染 (UTI) 儿童会出现这种情况。它有可能造成不可挽回的肾脏损害，特别是对于年幼的儿童。尽管在 VUR 儿童中广泛使用抗生素预防，但没有安慰剂对照研究证明其在预防肾损伤方面的临床益处。我们提出的双盲、安慰剂对照[原文如此]研究的主要目的是检验以下假设：对于 2 岁以上的 I-IV 级 VUR 儿童，长期使用抗生素预防是不必要的。我们的研究由来自北美儿科肾移植登记处 (NAPRTCS) 和中西部儿科肾病学联盟 (MWPNC) 附属 28 个中心的 28 名儿科肾病专家和 9 名儿科泌尿科专家共同努力，将招募 120 名 10 岁以下新诊断为 I-IV 级 VUR 的儿童来检验这一假设。我们建议对年龄不超过 2 岁或诊断 VUR 后至少 6 个月（以较晚者为准）的所有符合条件的受试者使用抗生素预防，然后将他们随机分为预防组和安慰剂组。 2 岁以上的儿童将在进入研究时直接随机分为预防组和安慰剂组。后续行动将包括每两年一次的诊所[原文如此]访问；每年进行肾脏成像、血液和尿液检查，以及排尿功能障碍 (DV) 和便秘评估；以及通过碘海醇清除率测量肾小球滤过率。通过随机化，我们将检验我们的第一个假设，即 2 岁后预防性使用抗生素不会降低 UTI 的频率、降低肾脏疤痕的风险或增强 VUR 的缓解。通过使用 DV 和便秘的客观评分，我们将检验我们的第二个假设，即无论是否长期使用抗生素预防，它们的存在都会延迟 VUR 的消退，并增加 UTI 和肾脏疤痕形成的频率。药物治疗失败的患者将被随机分为 Delfux 组或手术再植入组，以检验我们的第三个假设，即两种治疗方法在治愈率、尿路感染复发率或肾脏疤痕风险方面没有差异。 膀胱输尿管反流，即尿液从膀胱异常流入肾脏，在儿童中很常见，可能会导致肾脏损伤和高血压。目前的治疗多年来每天使用抗生素，但这可能没有必要，并且可能会造成一些伤害，包括对抗生素的耐药性，要求儿童进行昂贵且痛苦的放射学检查和外科手术，并引起父母的焦虑。这项研究将确定 VUR 儿童是否需要长期使用抗生素