Sample size
In the absence of data on KMC at home and the variability in KMC duration, we assumed an effect size of 0.5 for comparing the BEMPU vs. Control group. With an effect size of 0.5, 63 participants were required in each group for 80% power and 5% type I (Alpha) error. Considering that we may not have much loss to follow-up, a sample size of 128 neonates for the study was finalized, with 64 in each group for an effect size of 0.5.