1. SIFT A multi-centre randomised controlled trial of two speeds of daily increment of milk feeding in very preterm or very low birth weight infants Eligibility and Enrolment

2. Commencing the intervention After consent is obtained, randomisation will take place at the time the clinician is ready to start increasing the feed volume

3. Enrolment (1) Confirm eligibility –Baby meets inclusion criteria –No exclusion criteria apply (2) Obtain informed consent –Using verbal discussion, Parent Information Leaflet and Consent Form (3) Randomise – via the website

4. Eligibility Inclusion criteria Gestational age at birth <32 completed weeks, or birth weight <1,500 g The infant is receiving ≤30 ml/kg/day of milk at randomisation Written informed parental consent is obtained Exclusion criteria Infants with severe congenital anomalies Infants who, in the opinion of the treating clinician, have no realistic chance of survival Infants who are unlikely to be traceable for follow-up at 24 months of age (for example, infants of non-UK residents)

5. Parent Information Leaflet Should always be given to the parent(s) prior to consent being taken They should have sufficient time to read the information, or be talked through the form, and given time to consider

6. Printed on carbonless copy paper 1 copy to SIFT Coordinating Centre; 1 copy to Parent; 1 copy to SIFT Data Collection File; 1 copy to infant’s notes Informed Consent Form

7. Ensure the parent initials each box and does not tick them Both the clinician taking consent and the parent must print their name, sign, and date the form Informed Consent Form

8. Now you may need to:

9. When to randomise After consent is obtained, randomisation will take place at the time the clinician is ready to start increasing the feed volume

10. Entry form Complete Section A after baby confirmed eligible and parental consent obtained Randomise! (Section B) Sections C-E can be completed after randomisation

11. Randomisation http://www.rct.npeu.ox.ac.uk/sift

12. Thanks for your attention Best of luck with the study! NPEU Clinical Trials Unit Department of Public Health University of Oxford Old Road Campus Oxford OX3 7LF T: 01865 617 919 F: 01865 289 740 E: sift@npeu.ox.ac.uk www.npeu.ox.ac.uk/sift