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SIFT

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

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SIFT

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

  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 Leafletand Consent Form • (3) Randomise– via the website

  4. Eligibility Inclusion criteria Exclusion criteria Infants with a severe congenital anomaly 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) • 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

  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. Informed Consent Form • 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

  7. Informed Consent Form • Ensure the parent initials each box and does not tick them • Both the cliniciantaking consent and the parentmust print their name, sign, and date the 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. NPEU Clinical Trials Unit Nuffield Department of Population 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 Thanks for your attention Best of luck with the study!

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