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. 2023 Jun 16;2023(6):CD012937. doi: 10.1002/14651858.CD012937.pub3

Risk of bias for analysis 1.6 Number of infants with feed interruption episodes ≥ 12 hours.

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
Kaur 2015 Low risk of bias A computer‐generated block randomisation sequence with block size of 4 was prepared by a person not involved in clinical care, measurement of outcomes, or analysis of data. This randomisation sequence was kept in sequentially numbered sealed opaque envelopes. However, a fixed block size of 4 gives the chance to guess the allocation of every fourth infant in an unmasked study. Some concerns No data to assess if deviations arouse because of trial context. Low risk of bias All 80 randomised infants were included in the analysis. Some concerns Masking was not done. Low risk of bias Study protocol had been published. All proposed outcomes were reported. High risk of bias 'Some concerns' in two domains
Thomas 2018 Low risk of bias Randomization was completed using a computer‐generated random number table in unequal block sizes ranging from 4 to 12. Allocation concealment was done using sequentially numbered opaque sealed envelopes Low risk of bias Part 1: There were no deviation from intended intervention (Low risk)
Part 2: modified intention to treat analysis was used (Low risk)		 Low risk of bias All randomsied infants were accounted for. Some concerns Masking was not done. Some concerns Study protocol had not been published High risk of bias 'Some concerns' in two domains
Torrazza 2015 Low risk of bias A computer‐generated block randomisation sequence with variable block sizes was used. The randomisation sequence was kept in sequentially numbered sealed opaque envelopes (personal communication) Some concerns No data to assess if deviations arouse because of trial context. Low risk of bias All 61 randomised infants were included in the analysis. Some concerns Masking was not done Low risk of bias Study protocol had been published. All proposed outcomes were reported. High risk of bias 'Some concerns' in two domains.