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. |
Low risk of bias |
Though masking was not done, 'Time to regain birth weight' 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. |
Some concerns |
Some concerns in one domain, low risk in other domains. |