Recruitment/retention
A total of 3059 infants were screened for eligibility between April 2019 and November 2020, of whom 321 were randomised (161 to intervention and 160 to control), Figure 1. Baseline characteristics were balanced across the groups (Table 1). There were 61 withdrawals (41 intervention and 20 control, 19% attrition), with the majority (80%) occurring before the 2 week visit. The mean (SD) age at randomization was 1.9 (0.9) days.