The ADEPT Study Study Management .
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Transcript of The ADEPT Study Study Management .
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
• 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 < 10th centile for gestational age based on Child Growth Foundation Charts)
4. Postnatal age 20-48 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:
07623 947508
The randomisation process for ADEPT will be web based:
https://rct.npeu.ox.ac.uk/adept
ADEPT Randomisation Web Page
Recruitment & Entry Form:
ADEPT Feeding Regimens
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
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
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
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
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
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
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
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
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 discretionAt 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