ADEPT

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(No Transcript)
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Position of equipoise on when to start

• IUGR babies with AREDFV on antenatal Dopplers do
  have an increased risk of NEC
• BUTno evidence that delaying feeds is of benefit
• ANDdelaying feeds may increase-
• sepsis, cholestasis, chronic lung disease,
  duration of intensive care and length of hospital
  stay

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Should one delay feeds?The evidence

• Cochrane review
• early lt 4 days
• 2 small studies included
• 72 preterm infants only
• No differences seen for
• days feedings held, weight gain, conjugated
  jaundice, necrotizing enterocolitis and death.
• Kennedy KA, Tyson JE. Early versus delayed
  initiation of progressive enteral feedings for
  parenterally fed low birth weight or preterm
  infants

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Where does current practice come from?
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• Historical comparison in late 70s
• Switch from aggressive to conservative management
• Brown and Sweet (Mount Sinai N.Y)
• Proven NEC in
• 14 / 1,745 LBW infants 1970 1974
• 1 / 932 LBW infants 1974 - 1978

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• Started feeds at 5-7 days in at risk infants
  (not defined)
• 3 hourly feeds of water, then diluted formula
• Increased volume and concn over 16 days
• No statistics in the paper!
• Previous approach not described

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ADEPT Trial feeding regimes
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ADEPT Trial feeding regimes
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ADEPT Trial feeding regimes
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ADEPT Trial feeding regimes
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ADEPT Trial feeding regimes
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Day of initial milk feeding
Dorling McClure 1999 East Anglian SURVEY
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South West Neonatal Forum
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South West Neonatal Forum
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Why not increase faster?

• Schedules developed from Southwest practice
• 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
• Mothers own breast milk,
• Donated breast milk
• Infant formula (preterm / term)
• Advise infants with gestation lt34 weeks to be fed
  preterm formula within one week of starting milk.
  
• BMF if additional nutrition required once baby
  tolerating gt 150ml/kg/day.

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Exclusions and Deviations

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

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Exclusions and 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 exclusion or 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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Milk feeding and ventilation
2
13
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UAC presence the evidence

• 1 Small trial only
• 29 infants unable to exclude effect on NEC!
• Cohort papers significant confounding data (sick
  infants need a UAC)
• Davey, J Pediatr 1994. Feeding premature infants
  while low umbilical artery catheters are in
  place a prospective, randomized trial.

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Milk feeding and UAC
2
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Breast milk better than formula (n343)
of NEC

• McGuire, Anthony Arch Dis Child Fetal Neonatal Ed
  2003.
• Donor human milk versus formula for preventing
  necrotising enterocolitis in preterm infants
  systematic review.

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A Breast Feeding Friendly Trial

• Please encourage EBM as much as possible!

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Thank you for your attentionAny Questions?
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(No Transcript)
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Speed of advance

• Kennedy Tyson. Rapid versus slow rate of
  advancement of feedings for promoting growth and
  preventing necrotizing enterocolitis in
  parenterally fed low-birth-weight infants
  (Cochrane Review).
• 369 babies from three trials
• gt 20 v lt 20 cc/kg/day increase

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Speed of advance

• faster increase in feed volumes
• reduction in days to full enteral feeding
• less days to regain birth weight
• NO effect on NEC
• RR 0.90
• 95 CI 0.46 - 1.77

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Trophic feeds / MEF etc

• Stimulate endocrine and motor gut function
• 10- 20 ml/kg/day for gt 48 hours
• Cochrane study of 6 trials
• Tyson JE, Kennedy KA. Minimal enteral nutrition
  for promoting feeding tolerance and preventing
  morbidity in parenterally fed infants.

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MEF Cochrane review

• Outcomes significantly affected by MEF
• length of stay
• WMD 15.6 days less stay in MEF group (95 CI
  8.5 to 22.8)
• days to full feeding
• WMD 2.7 days less in MEF group
  (95 CI 0.98 to 4.4).
• No difference in NEC or death rates
• last updated in 1997 3 studies since

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Further studies on MEN

• Schanler
• n171, NEC 13 in MEF, 10 controls
• McClure
• n 100, NEC 1 in MEF, 2 controls
• Van Elberg
• IUGR infants, n42, NEC 0 in MEF, 1 control
• Added to previous meta-analysis NEC 10.5 in
  MEF, 9.4 controls (RR 1.07,
  95CI 0.84-1.36)

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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)
• NEC
• Secondary outcomes
• Death
• Duration of level 1 and level 2 IC
• Growth wt and OFC z-scores at 36w d/c
• Sepsis, cholestasis, bowel perforation, CLD

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ADEPT sample size

• Time to reach full feeds
• data taken from East Anglia
• 380 babies needed to show difference of 3 days
  with 90 power
• NEC
• Incidence approx 15
• 400 babies needed to show reduction to 7.5 with
  60 power

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Thank you for your attentionAny Questions?