Position of equipoise on when to start
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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 BUT…no evidence that delaying feeds is of benefit AND…delaying feeds may increase;-

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Position of equipoise on ‘when to start’

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Position of equipoise on when to start

Position of equipoise on ‘when to start’

  • IUGR babies with AREDFV on antenatal Dopplers do have an increased risk of NEC

  • BUT…no evidence that delaying feeds is of benefit

  • AND…delaying feeds may increase;-

    • sepsis, cholestasis, chronic lung disease, duration of intensive care and length of hospital stay


Should one delay feeds the evidence

Should one delay feeds?The ‘evidence’

  • Cochrane review

  • ‘early’ < 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


Position of equipoise on when to start

Where does current practice come from?


Position of equipoise on when to start

  • 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


Position of equipoise on when to start

  • 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


Position of equipoise on when to start

‘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 Trial feeding regimes


Position of equipoise on when to start

‘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 Trial feeding regimes


Position of equipoise on when to start

‘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 Trial feeding regimes


Position of equipoise on when to start

‘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 Trial feeding regimes


Position of equipoise on when to start

‘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 Trial feeding regimes


Day of initial milk feeding

Day of initial milk feeding

Dorling & McClure 1999 East Anglian SURVEY


Position of equipoise on when to start

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

South West Neonatal Forum


Position of equipoise on when to start

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

South West Neonatal Forum


Why not increase faster

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


Milk types

Milk types

  • Choice of milk

    • Mother’s own breast milk,

    • Donated breast milk

    • Infant formula (preterm / term)

      • Advise infants with gestation <34 weeks to be fed preterm formula within one week of starting milk.

  • BMF if additional nutrition required once baby tolerating > 150ml/kg/day.


Exclusions and deviations

Exclusions and Deviations

  • Withholding feeds

  • or deviating from feeding schedule

  • for feed intolerance or clinical deterioration

  • At local clinician’s discretion.


Exclusions and deviations1

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 <750 grams birth weight)

    • Mihatsch et al. J Pediatr Gastroenterol Nutr 2002;35:144-8.


Restarting after exclusion or deviation

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


Not reasons for deviation

Not reasons for deviation

  • type of milk available

  • ventilation status

  • presence of an UAC / UVC


Position of equipoise on when to start

Milk feeding and ventilation

2

13


Uac presence the evidence

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.


Position of equipoise on when to start

Milk feeding and UAC

2

13


Breast milk better than formula n 343

Breast milk better than formula (n=343)

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.


A breast feeding friendly trial

A Breast Feeding Friendly Trial

  • Please encourage EBM as much as possible!


Thank you for your attention any questions

Thank you for your attentionAny Questions?


Speed of advance

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

  • > 20 v < 20 cc/kg/day increase


Speed of advance1

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


Trophic feeds mef etc

Trophic feeds / MEF etc

  • Stimulate endocrine and motor gut function

  • 10- 20 ml/kg/day for > 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.


Mef cochrane review

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


Further studies on men

Further studies on MEN

  • Schanler

    • n=171, NEC 13 in MEF, 10 controls

  • McClure

    • n= 100, NEC 1 in MEF, 2 controls

  • Van Elberg

    • IUGR infants, n=42, NEC 0 in MEF, 1 control

  • Added to previous meta-analysis: NEC 10.5% in MEF, 9.4% controls (RR 1.07, 95%CI 0.84-1.36)


Adept exclusions

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

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


Adept sample size

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


Thank you for your attention any questions1

Thank you for your attentionAny Questions?


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