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. 2019 Apr 1;2019(4):CD001534. doi: 10.1002/14651858.CD001534.pub4

Lohr 1977.

Methods
  • Study design: cross‐over RCT

  • Duration of study: not reported

  • Duration of follow‐up: 12 months

Participants
  • Country: USA

  • Setting: single centre

  • Girls with at least 3 culture‐proven episodes of bacteriuria in the previous year; no evidence of parenchymal damage or gross structural abnormality requiring surgery

  • Number: 18

  • Mean age (range): 6.4 years (3 to 13 years)

  • VUR: 1

  • Previously undergone urinary tract surgery for urethral dilatation: 4

  • Exclusion criteria: G6PD deficiency

Interventions Treatment group
  • Nitrofurantoin

    • 50 mg/d for children > 20 kg

    • 25 mg/d for children < 20 kg


Control group
  • Placebo tablets matched to both tablet sizes


Cross‐over
  • Antibiotic or placebo for 6 months then crossed over to alternate for 6 further months

Outcomes
  • Number of repeat symptomatic and asymptomatic infections/group

Notes
  • Funding source: "Supported in part by a grant from Eaton Laboratories"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised, method of randomisation was not reported
Allocation concealment (selection bias) Low risk States the code was unknown to investigators
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Matching placebo used so couldn't tell which drug the child was taking
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No missing data apparent
Selective reporting (reporting bias) Unclear risk Single outcome of bacteriuria, appears to have included symptomatic and asymptomatic events
Other bias Unclear risk Methodology details poorly reported