Risk of bias for analysis 2.1 Risk of necrotising enterocolitis stage ≥ 2.
Study | Bias | |||||||||||
Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | |||||||
Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | |
Singh 2018 | Low risk of bias | The randomization sequence was computer generated and permuted, even numbered, randomly varying block sizes were generated with a 1:1 allocation ratio. The allocation sequence was concealed using serially numbered opaque sealed envelopes. | Low risk of bias | Part 1: There were no deviations from the intended intervention (Low risk) Part 2: Modified intention to treat analysis was used (Low risk) |
Low risk of bias | All 87 randomised infants were included in the analysis. | Low risk of bias | Though masking was not done, 'NEC' is an objective outcome and is less prone to detection bias. | Low risk of bias | Study protocol had been published. All proposed outcomes were reported. | Low risk of bias | 'Low risk' in all domains. |