The ADEPT Study Study Management
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 Randomisation to early or late enteral feeding Primary outcome: days to full enteral feeding and necrotising enterocolitis
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 < 10 th centile for gestational age based on Child Growth Foundation Charts) 4. Postnatal age hours Infant Eligibility:
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
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
ADEPT Data Collection Entry Form Daily Feed Log 36 Week Form Discharge/Transfer Form
ADEPT Data Collection Additional forms: Episodes of NEC or Other Abdominal Pathology Form Serious Adverse Event (SAE) & Suspected Unexpected Serious Adverse Reaction (SUSAR) Form
There will be a telephone randomisation back up: The randomisation process for ADEPT will be web based:
ADEPT Randomisation Web Page
Recruitment & Entry Form:
ADEPT Feeding Regimens
ADEPT Study Feeding Regimens ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & hours onwards (day 7+) Progress with feeding according to tables 1 & 2
ADEPT Study Feeding Regimens ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & hours onwards (day 7+) Progress with feeding according to tables 1 & 2
ADEPT Study Feeding Regimens ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & hours onwards (day 7+) Progress with feeding according to tables 1 & 2
ADEPT Study Feeding Regimens ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & hours onwards (day 7+) Progress with feeding according to tables 1 & 2
ADEPT Study Feeding Regimens ‘early’ ‘late’ 0-24 hours (day 1) Nil by mouth hours (day 2) Start milk feeds according to tables 1 & 2 Nil by mouth hours (day 3-5) Progress with feeding according to tables 1 & 2 Nil by mouth hours (day 6) Progress with feeding according to tables 1 & 2 Start milk feeds according to tables 1 & hours onwards (day 7+) Progress with feeding according to tables 1 & 2
Day of feeding Volume of milk according to birth weight (ml/kg/HOUR) < 600g g g g 1250g Increase as required
Day of feeding Volume of milk according to birth weight (ml/kg/DAY) <600g g g g 1250g Increase as required
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
Daily Feed Log
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
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
Deviations Withholding feeds or deviating from feeding schedule for feed intolerance or clinical deterioration At local clinician’s discretion
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.
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
Not reasons for deviation Type of milk available Ventilation status Presence of an UAC/UVC
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
Study Entry Form
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