Statistical analysis
RECRUITMENT, REGRESSIONS
The analyses were conducted using Stata/MP version 16.1 (StataCorp, Texas). All patients were included with the intention to treat (ITT) population, excluding only those who withheld or withdrew consent to data collection. Children were analysed according to the group they were randomised to (based on site and date of recruitment), irrespective of whether the treatment allocated was received.Potential outcome measures were summarised using counts and percentages (for binary outcomes), median and IQR (for all continuous outcome) and means and standard deviations (length of stay and duration of treatment) and reported by intervention group and study period.To account for cluster randomisation, multilevel logistic or generalised linear regressions were used to estimate potential treatment effects. The effect estimate was calculated as the interaction between treatment group and study period, and reported as either odds ratio with 95% CI (binary outcomes) or difference in means with 95% CIs (continuous outcomes).As this was a pilot cRCT and not powered to detect differences in outcomes, analyses are treated as exploratory and were mainly descriptive. P values are not calculated or quoted.