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

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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 - PowerPoint PPT Presentation

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Page 1: The ADEPT Study

The ADEPT Study

Study Management

www.npeu.ox.ac.uk/adept

Page 2: The ADEPT Study

ADEPT Study Management

• Study design

• Eligibility and exclusions

• Study outcomes

• Randomisation and entry

• Feeding regimens

Page 3: The ADEPT Study

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

Page 4: The ADEPT Study

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

Infant Eligibility:

Page 5: The ADEPT Study

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

Page 6: The ADEPT Study

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

Page 7: The ADEPT Study

ADEPT Data Collection

• Entry Form

• Daily Feed Log

• 36 Week Form

• Discharge/Transfer Form

Page 8: The ADEPT Study

ADEPT Data Collection

Additional forms:

• Episodes of NEC or Other Abdominal Pathology Form

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

Page 9: The ADEPT Study

There will be a telephone randomisation back up:

07623 947508

The randomisation process for ADEPT will be web based:

https://rct.npeu.ox.ac.uk/adept

Page 10: The ADEPT Study

ADEPT Randomisation Web Page

Page 11: The ADEPT Study

Recruitment & Entry Form:

Page 12: The ADEPT Study
Page 13: The ADEPT Study

ADEPT Feeding Regimens

Page 14: The ADEPT Study

ADEPT Study Feeding Regimens

‘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

Page 15: The ADEPT Study

ADEPT Study Feeding Regimens

‘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

Page 16: The ADEPT Study

ADEPT Study Feeding Regimens

‘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

Page 17: The ADEPT Study

ADEPT Study Feeding Regimens

‘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

Page 18: The ADEPT Study

ADEPT Study Feeding Regimens

‘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

Page 19: The ADEPT Study

Day offeeding

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

Page 20: The ADEPT Study

Day offeeding

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 - 1088 72 84 84 96 - 108 120-1329 84 96 96-108 120-132 144-15010 96 108-120 120-132 144-150  

11 108-120 132-144 144-150    

12 132-144 150      

13 150        

14 Increase as required

Page 21: The ADEPT Study

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

Page 22: The ADEPT Study

Daily Feed Log

Page 23: The ADEPT Study

Daily Feed Log

Page 24: The ADEPT Study

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

Page 25: The ADEPT Study

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

Page 26: The ADEPT Study

Deviations

• Withholding feeds or deviating from feeding schedule for feed intolerance or clinical deterioration

At local clinician’s discretionAt local clinician’s discretion

Page 27: The ADEPT Study

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.

Page 28: The ADEPT Study

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

Page 29: The ADEPT Study

Not reasons for deviation

• Type of milk available

• Ventilation status

• Presence of an UAC/UVC

Page 30: The ADEPT Study

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

Page 31: The ADEPT Study

Study Entry Form

Page 32: The ADEPT Study

Episodes of NEC or other Abdominal Pathology Form

Page 33: The ADEPT Study

Serious Adverse Event (SAE) & Suspected Unexpected Serious Adverse Reaction

(SUSAR) Form

Page 34: The ADEPT Study

36 Week Form

Page 35: The ADEPT Study

Discharge or Transfer Form