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The ADEPT Study

The ADEPT Study. Study Management. www.npeu.ox.ac.uk/adept. ADEPT Study Management. Study design Eligibility and exclusions Study outcomes Randomisation and entry Feeding regimens. Study Design. Premature babies who have abnormal antenatal Doppler studies

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The ADEPT Study

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  1. The ADEPT Study Study Management www.npeu.ox.ac.uk/adept

  2. ADEPT Study Management • Study design • Eligibility and exclusions • Study outcomes • Randomisation and entry • Feeding regimens

  3. Study Design • Premature babies who have abnormal antenatal Doppler studies • Randomisation to early or late enteral feeding • Primary outcome: days to full enteral feeding and necrotising enterocolitis

  4. Infant Eligibility: • 1. Gestational age up to and including 34 weeks + 6 days (dated by antenatal ultrasound or clinically) • 2. Antenatal ultrasound showing either • a) absent or reversed end diastolic flow velocities on at least • 50% of the Doppler waveforms from the umbilical artery • on at least one occasion during pregnancy • or • b) cerebral redistribution, defined as occurring when both • the umbilical artery pulsatility index is >95th centile and • the middle cerebral artery pulsatility index is <5th centile • for gestational age • 3. Small for gestational age (birth weight < 10th centile for gestational age based on Child Growth Foundation Charts) • 4. Postnatal age 20-48 hours

  5. ADEPT Exclusions • Major congenital abnormality • Twin-twin transfusion • Intra-uterine or exchange transfusion • Rhesus haemolysis • Multi-organ failure prior to randomisation • Inotrope support prior to randomisation • Already received enteral feed

  6. ADEPT Outcomes • Primary outcomes • Time to reach full enteral feeds (for 72 hours) • Necrotising enterocolitis • Secondary outcomes • Death • Duration of level 1 and level 2 Intensive Care • Growth: weight and occipital frontal circumference z-scores at 36 weeks & discharge • Sepsis, cholestasis, bowel perforation, chronic lung disease

  7. ADEPT Data Collection • Entry Form • Daily Feed Log • 36 Week Form • Discharge/Transfer Form

  8. ADEPT Data Collection Additional forms: • Episodes of NEC or Other Abdominal Pathology Form • Serious Adverse Event (SAE) & Suspected Unexpected Serious Adverse Reaction (SUSAR) Form

  9. The randomisation process for ADEPT will be web based: https://rct.npeu.ox.ac.uk/adept • There will be a telephone randomisation back up: • 07623 947508

  10. ADEPT Randomisation Web Page

  11. Recruitment & Entry Form:

  12. ADEPT Feeding Regimens

  13. ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth Nil by mouth 24-48 hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth 48-119 hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth 120-143 hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & 2 144 hours onwards (day 7+) Progress with feeding according to tables 1 & 2 Progress with feeding according to tables 1 & 2 ADEPT Study Feeding Regimens

  14. ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth Nil by mouth 24-48 hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth 48-119 hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth 120-143 hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & 2 144 hours onwards (day 7+) Progress with feeding according to tables 1 & 2 Progress with feeding according to tables 1 & 2 ADEPT Study Feeding Regimens

  15. ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth Nil by mouth 24-48 hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth 48-119 hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth 120-143 hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & 2 144 hours onwards (day 7+) Progress with feeding according to tables 1 & 2 Progress with feeding according to tables 1 & 2 ADEPT Study Feeding Regimens

  16. ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth Nil by mouth 24-48 hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth 48-119 hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth 120-143 hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & 2 144 hours onwards (day 7+) Progress with feeding according to tables 1 & 2 Progress with feeding according to tables 1 & 2 ADEPT Study Feeding Regimens

  17. ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth Nil by mouth 24-48 hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth 48-119 hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth 120-143 hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & 2 144 hours onwards (day 7+) Progress with feeding according to tables 1 & 2 Progress with feeding according to tables 1 & 2 ADEPT Study Feeding Regimens

  18. Day of feeding Volume of milk according to birth weight (ml/kg/HOUR) <600g 600-749g 750-999g 1000-1249g 1250g 1 0.5 0.5 0.5 0.5 1.0 2 0.5 0.5 0.5 1.0 1.5 3 0.5 1.0 1.0 1.5 2.0 4 1.0 1.5 1.5 2.0 2.5 5 1.5 2.0 2.0 2.5 3.0 6 2.0 2.5 2.5 3.0 3.5 7 2.5 3.0 3.0 3.5 4.0 - 4.5 8 3.0 3.5 3.5 4.0 - 4.5 5.0 - 5.5 9 3.5 4.0 4.0 - 4.5 5.0 - 5.5 6.0 6.25 10 4.0 4.5 - 5.0 5.0 - 5.5 6.0 - 6.25 11 4.5 - 5.0 5.5 - 6.0 6.0-6.25 12 5.5 - 6.0 6.25 13 6.25 14 Increase as required

  19. Day of feeding Volume of milk according to birth weight (ml/kg/DAY) <600g 600-749g 750-999g 1000-1249g 1250g 1 12 12 12 12 24 2 12 12 12 24 36 3 12 24 24 36 48 4 24 36 36 48 60 5 36 48 48 60 72 6 48 60 60 72 84 7 60 72 72 84 96 - 108 8 72 84 84 96 - 108 120-132 9 84 96 96-108 120-132 144-150 10 96 108-120 120-132 144-150 11 108-120 132-144 144-150 12 132-144 150 13 150 14 Increase as required

  20. Daily Feed Log • Start on day 1 after birth • Document all ‘feeds’ – parenteral and enteral • Measures of feed tolerance • Complete for at least 28 days….and until on full feeds of 150 ml/kg for 3 days

  21. Daily Feed Log

  22. Daily Feed Log

  23. How were Feeding Regimens decided? • Schedules developed from practice in the South West • Mid point of a ‘reasonable’ approach • ‘Too fast’ might lead to accusation of raised NEC not representative of UK experience

  24. Milk Types • Choice of milk in descending order of preference: • a. Mother’s own breast milk • b. Donated breast milk • c. Infant formula (preterm/term) • - Advise infants with gestation <34 weeks to be fed preterm formula within one week of starting milk • Breast Milk Fortifier if additional nutrition required • once baby tolerating >150ml/kg/day

  25. Deviations • Withholding feeds or deviating from feeding schedule for feed intolerance or clinical deterioration At local clinician’s discretion

  26. Deviations • Gastric residuals common • Providing the infant is well and has no abnormal abdominal signs it is usually safe to continue with enteral feeds when gastric aspirate is 2-3 ml or less (2 ml if <750 grams birth weight) • Mihatsch et al. J Pediatr Gastroenterol Nutr 2002;35:144-8.

  27. Restarting after deviation • Either • restart from day 1 of schedule • or • re-start at the volume previously tolerated then increase as schedule • or • hold for one or more days at a certain volume and then increase as schedule

  28. Notreasons for deviation • Type of milk available • Ventilation status • Presence of an UAC/UVC

  29. ADEPT Data Collection • Entry Form • Daily Feed log • Episodes of NEC or other Abdominal Pathology Form • Serious Adverse Event (SAE) & Suspected Unexpected Serious Adverse Reaction (SUSAR) Form • 36 Week Form • Discharge or Transfer Form

  30. Study Entry Form

  31. Episodes of NEC or other Abdominal Pathology Form

  32. Serious Adverse Event (SAE) & Suspected Unexpected Serious Adverse Reaction (SUSAR) Form

  33. 36 Week Form

  34. Discharge or Transfer Form

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