Primary Vesicoureteral Reflux in Children

儿童原发性膀胱输尿管反流

• 批准号: 7036386
• 负责人: TEJ K MATTOO
• 金额: $ 45.28万
• 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/7036386
• 关键词: antiinfective agents; biomaterials; chemoprevention; child (0-11); clinical research; clinical trials; constipation; cooperative study; disease /disorder prevention /control; human subject; human therapy evaluation; implant; injury; kidney disorder; longitudinal human study; patient oriented research; pediatric pharmacology; pediatrics; relapse /recurrence; scars; urinary bladder disorder; urinary tract imaging /visualization; urinary tract infection; urinary tract surgery; urination disorder

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，发生在8-50%的尿路感染（UTI）儿童中。它有可能造成不可修复的肾损伤，特别是在年幼的儿童中。尽管抗生素预防在VUR儿童中广泛使用，但尚无安慰剂对照研究证明其在预防肾损伤方面的临床获益。我们提出的双盲、安慰剂对照研究的主要目的是检验这一假设，即在2岁以上的I-IV级VUR儿童中延长抗生素预防是不必要的。我们的研究是来自北美儿科肾移植登记处（NAPRTCS）和中西部儿科肾脏病联盟（MWPNC）附属的28个中心的28名儿科肾脏病学家和9名儿科泌尿科医生的共同努力，将通过招募120名10岁以下新诊断的I-IV级VUR儿童来验证这一假设。我们建议对所有符合条件的受试者使用抗生素预防，年龄不超过2岁或自诊断VUR起至少6个月（以较晚者为准），然后将他们随机分为预防组和安慰剂组。>2岁的儿童将在进入研究时直接随机分为预防组和安慰剂组。随访将包括一年两次的临床访视;每年一次的肾成像、血液和尿液检查，以及功能障碍性排尿（DV）和便秘的评估;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，降低肾瘢痕形成的风险，或提高VUR的消退。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，即无论长期抗生素预防如何，它们的存在都会延迟VUR的消退，并增加UTI和肾瘢痕形成的频率。药物治疗失败的患者将随机分为Delfux组或手术再植组，以检验我们的第三个假设，即两种治疗在治愈率、UTI复发率或肾瘢痕形成风险方面没有差异。 膀胱输尿管反流，尿液从膀胱进入肾脏的异常流动，在儿童中很常见，可能导致肾脏损伤和高血压。目前的治疗方法多年来每天使用抗生素，但这可能不是必要的，可能会造成一些伤害，包括对抗生素的耐药性，需要儿童进行昂贵而痛苦的放射学检查和外科手术，并引起父母的焦虑。这项研究将确定是否有必要长期抗生素在儿童VUR