Chatfield 1991.
Methods | RCT. Duration: follow up to each child's third birthday. Multicentre in Wales and West Midlands (UK) (number of centres not stated). |
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Participants | Infants with CF diagnosed by neonatal screening or clinically (alternate weeks).
Followed up to age 3 years. n = 132: 57 prophylaxis; 75 'as required'. Mean (SD) age at diagnosis: 122 (255) days prophylaxis; 260 (379) 'as required'. Data available at 1, 2 & 3 years. |
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Interventions | Continuous oral flucloxacillin versus intermittent antibiotics 'as required'. | |
Outcomes | Growth; inpatient days; participants with isolates of common pathogens; P aeruginosa. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described, unclear. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | High risk | Unblinded. No placebo. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis: not possible (infants with meconium ileus not randomised and therefore excluded from analysis). 1 participant lost to follow up and 1 infant died. |
Selective reporting (reporting bias) | Unclear risk | Study reported outcomes up to 3 years of age. Only summary statistics have been presented in abstracts, and full paper describes the methodology, but does not present results by antibiotic groups. |
Other bias | High risk | Infants with meconium ileus not randomised. Additional information from the authors. |