Table 2.
Schedule of trial procedures
Procedures | From the day of birth (day 0) up to midnight on day 3 of life | Day 4, 14 (E1 & E2) | Day 4 to 7 | Day 21 (E3) | 32 weeks post-menstrual age (exploratory timepoint) | 36 weeks post-menstrual age (F1), 9 and 18 weeks after estimated date of delivery (F2) |
---|---|---|---|---|---|---|
Only applies if infant born at <27 weeks gestation | In the abbreviated follow-up period the trial completes at F1 | |||||
Informed consent | ✔ | |||||
Eligibility assessment | ✔ | |||||
Randomisation | ✔ | |||||
Baseline Questionnaire | ✔ | |||||
Maternal training and assessment on use of scales | ✔ | |||||
Check-in and verify accurate use of scales | ✔ | |||||
Questionnaire & 24-h expressing log | ✔ | ✔ | ||||
Maternal mental health questionnaires | ✔ | |||||
Text message response | ✔ | ✔ |