THE ADEPT STUDY ADEPT DATA FORMS The user’s view Dr Alison Leaf Southmead Hospital, Bristol

Consent Form Clear and easy to use Fathers can only sign if married to baby’s mother Ensure use ball point pen to get writing through the 4 layers Ensure parent initials box, rather than ticks Give top copy to parents

Entry form Must have items 1-9 before randomisation This is good opportunity to get to know your obstetricians! Randomisation programme prints out allocation Doppler info is most detailed – best to try and collect all info before mum discharged

Daily feed log Most important data Ensure all staff know when and how to complete – and do every day ? Insert weight only when re-weighed Only total volumes of enteral / IV fluid Measures of feed intolerance: no need to tick box, insert letter from key to explain

Discharge / transfer form Contact details important for follow-up Complete data for all diagnoses/treatments in your hospital For NEC, sepsis, cholestasis, days of IC/HD care – refer to definitions in protocol and Handbook For transfers give full contact details of new hospital

NEC / Abdominal Pathology Best to start this at time diagnosis is first considered and up-date as process evolves Final diagnosis – at top but ?complete last - ensure consultant agrees with diagnosis listed! Modified Bell’s Criteria – on back of form, in protocol and in Handbook ? Stage 1A may be under-reported

36-week form Simple to complete Provides growth data to calculate z-scores Provides data on weeks Reminds you that baby is in ADEPT if discharge or transfer is imminent!

SAE / SUSAR Important to do if unexpected event occurs Must be submitted within 48 hours SAE = serious adverse event Death, tamponade, CV-line complication SUSAR = suspected unexpected serious adverse reaction If in doubt contact ADEPT office

General points Multi-page forms - ensure stay together; ?staple 28-day log at top Write in black biro - ensure writing goes through all pages; blue does not photocopy well Complete as soon as possible, keep a copy, send to Mary - FREEPOST envelopes!