The ADEPT Study

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The ADEPT Study

• Study Management

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

• Study design
• Eligibility and exclusions
• Study outcomes
• Randomisation and entry
• Feeding regimens

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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

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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 gt95th centile and
the middle cerebral artery pulsatility index is
lt5th centile for gestational age 3.
Small for gestational age (birth weight lt 10th
centile for gestational age based on Child Growth
Foundation Charts) 4. Postnatal age 20-48 hours
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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

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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

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ADEPT Data Collection

• Entry Form
• Daily Feed Log
• 36 Week Form
• Discharge/Transfer Form

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ADEPT Data Collection

• Additional forms
• Episodes of NEC or Other Abdominal Pathology Form
• Serious Adverse Event (SAE) Suspected
  Unexpected Serious Adverse Reaction (SUSAR) Form

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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
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ADEPT Randomisation Web Page
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Recruitment Entry Form
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ADEPT Feeding Regimens
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ADEPT Study Feeding Regimens
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ADEPT Study Feeding Regimens
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ADEPT Study Feeding Regimens
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ADEPT Study Feeding Regimens
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ADEPT Study Feeding Regimens
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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

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Daily Feed Log
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Daily Feed Log
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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

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Milk Types

• Choice of milk in descending order of
  preference
• a. Mothers own breast milk
• b. Donated breast milk
• c. Infant formula (preterm/term)
• - Advise infants with gestation lt34 weeks
  to be fed preterm formula within one week of
  starting milk
• Breast Milk Fortifier if additional nutrition
  required
• once baby tolerating gt150ml/kg/day

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Deviations

• Withholding feeds or deviating from feeding
  schedule for feed intolerance or clinical
  deterioration
• At local clinicians discretion

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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 lt750 grams birth weight)
• Mihatsch et al. J Pediatr Gastroenterol Nutr
  200235144-8.

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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

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Not reasons for deviation

• Type of milk available
• Ventilation status
• Presence of an UAC/UVC

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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

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Study Entry Form
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Episodes of NEC or other Abdominal Pathology Form
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Serious Adverse Event (SAE) Suspected
Unexpected Serious Adverse Reaction (SUSAR) Form
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36 Week Form
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Discharge or Transfer Form