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. 2019 Jan 18;2019(1):CD011825. doi: 10.1002/14651858.CD011825.pub2

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
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
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
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.