title: The Swedish reflux trial in children: I. Study design and study population characteristics.
abstract: OBJECTIVE
  We compared the rates of febrile urinary tract infection, kidney damage and reflux resolution in children with vesicoureteral reflux treated in 3 ways, including antibiotic prophylaxis, endoscopic therapy and surveillance with antibiotics only for symptomatic urinary tract infection.
  
  
  METHODS
  Children 1 to younger than 2 years with grade III-IV reflux were recruited into this prospective, open, randomized, controlled, multicenter study and followed for 2 years after randomization. The main study end points were recurrent febrile urinary tract infection, renal status on dimercapto-succinic acid scintigraphy and reflux status. Outcomes were analyzed by the intent to treat principle.
  
  
  RESULTS
  During a 6-year period 128 girls and 75 boys entered the study. In 96% of cases reflux was detected after urinary tract infection. The randomization procedure was successful and resulted in 3 groups matched for relevant factors. Recruitment was slower than anticipated but after patients were entered adherence to the protocol was good. Of the children 93% were followed for the intended 2 years without a treatment arm change. All except 2 patients completed 2-year followup scintigraphy.
  
  
  CONCLUSIONS
  Recruitment was difficult but a substantial number of children were entered and randomly assigned to 3 groups with similar basic characteristics. Good adherence to the protocol made it possible to address the central study questions.
authors.affiliation: Pediatric Uro-Nephrologic Center, Queen Silvia Children's Hospital, University of Gothenburg, Göteborg, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Brandström
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Esbjörner
authors.forename: Maria
authors.initials: M
authors.lastname: Herthelius
authors.forename: Gundela
authors.initials: G
authors.lastname: Holmdahl
authors.forename: Göran
authors.initials: G
authors.lastname: Läckgren
authors.forename: Tryggve
authors.initials: T
authors.lastname: Nevéus
authors.forename: Ulla
authors.initials: U
authors.lastname: Sillén
authors.forename: Rune
authors.initials: R
authors.lastname: Sixt
authors.forename: Ingrid
authors.initials: I
authors.lastname: Sjöberg
authors.forename: Eira
authors.initials: E
authors.lastname: Stokland
authors.forename: Ulf
authors.initials: U
authors.lastname: Jodal
authors.forename: Sverker
authors.initials: S
authors.lastname: Hansson
mesh_terms: D019072:Antibiotic Prophylaxis; D004724:Endoscopy; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011159:Population Surveillance; D011446:Prospective Studies; D012107:Research Design; D013548:Sweden; D019783:Technetium Tc 99m Dimercaptosuccinic Acid; D014463:Ultrasonography / Q000379:methods; D014552:Urinary Tract Infections / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D014567:Urography; D014718:Vesico-Ureteral Reflux / Q000175:diagnosis* / Q000209:etiology / Q000628:therapy*
chemical_list: D019783:Technetium Tc 99m Dimercaptosuccinic Acid