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Table 2 Schedule of trial procedures

From: Comparing the effect of a lactation-specific relaxation and visualisation intervention versus standard care on lactation and mental health outcomes in mothers of very premature infants (the EXPRESS trial): study protocol for a multi-centre, unmasked, randomised, parallel-group trial

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

    

✔

✔