Aly 2007.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 60 children (macrolide n = 30, placebo n = 30) Age in days (median (range)): macrolide: 2.0 (2.0 to 24.0), placebo: 2.0 (2.0 to 10.0) Setting: secondary care |
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Interventions |
Indication: feeding intolerance in preterm infants Type of macrolide: erythromycin ethylsuccinate Route: per oral Dose per day: 3 mg/kg Duration of treatment: the study medicine was to stop once the primary endpoint was achieved Total treatment dose: N/A |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: no Adverse events ascertainment: unclear Adverse events: data reported Antimicrobial resistance: not reported Death: data reported |
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Funding sources | None reported. | |
Notes | Concomitant medication: yes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation |
Allocation concealment (selection bias) | Low risk | Allocation concealed by cards provided in consecutively numbered, opaque, sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both active drug and placebo were mixed thoroughly into the milk feeds by designated staff not involved in the clinical management of the infants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Parents and staff blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low dropout, similar across groups |
Selective reporting (reporting bias) | Unclear risk | Adverse events not stated as an outcome and unclear ascertainment. Adverse events/complications reported. |
Other bias | Low risk | None were identified. |