N'E'T' Necrotising EnterocolitisTrial

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N.E.T. Necrotising EnterocolitisTrial

Primary peritoneal drainage in necrotising
enterocolitisprospective, randomised
controlled, multicentre trial
The Institute of Child Health and Great Ormond
Street Hospital for Children London, UK
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Systematic reviewperitoneal drainage in NEC

• 45 retrospective/cohort studies
• no randomised trial
• in spite of the lack of strong evidence,
  peritoneal drainage has become a common method of
  treating complicated NEC in ELBW

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Aim

• To determine if peritoneal drainage improves
  survival of extremely low birth weight infants
  with complicated NEC or with isolated perforation

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Collaborators
13
2
1
1
2
10
2
2
2
1
1
3
2
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Inclusion criteria
1. ?1000g weight
2.
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Exclusion criteria

• Bilateral grade 4 IVH
• multiple episodes of NEC
• previous laparotomy for NEC
• previous insertion of PPD for NEC
• NICU with no surgical facilities

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End points

• Primary
• Survival rate at 1 and 6 months
• Secondary
• Time to death and cause of death
• Hospital stay
• Intestinal absorptive function
• Long term intestinal complications
• Intra-ventricular haemorrhage
• Respiratory function

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What to do when you have a patient...

• ...the who, what, how and where

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Randomisation Form A

• weight
• gestational age
• platelets
• mechanical ventilation
• inotropic support
• centre with facilities for on-site laparotomy
• Country
• suspected diagnosis

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Pre-op management

• Same for all patients
• Xray
• Cranial USS

?
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Data at Enrolment Form C

• Medical history
• Risk factors - PDA, drugs, feeds
• Ventilation details
• Inotropes
• Antibiotics
• IVH
• Vital signs / Bloods / Urine output

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Trial design
Randomisation
Primary Peritoneal Drainage
Primary Laparotomy
12 Hours
Stable or improving
Deterioration
Delayed laparotomy
Continue with drain
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Peritoneal drainage insertion
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Primary Peritoneal Drain Form E

• date / time
• site
• number
• operator
• clinical status post drain
• drainage material
• bleeding

• Drain removal
• date / time
• reason
• stopped draining
• patient improved
• patient deteriorated

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Laparotomy - Form F
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Laparotomy - Form F
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Daily Data Sheet

• Ventilation
• Inotropic support
• Urine output
• Vital signs
• Antibiotics
• Blood results

• Heart rate
• Respiratory rate
• CRT
• MAP
• Core temp
• Peripheral temp

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Deterioration

• ? Abdominal distension / discoloration
• ? / persistent pneumoperitoneum
• palpable mass
• persistent intestinal obstruction
• no passage of stools
• worsening organ failure score

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Post-op management

• recovery
• deterioration delayed laparotomy
• recurrent NEC 2o laparotomy
• complication 2o laparotomy
• death
• cranial USS at 2 weeks

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Follow Up Form I J

• At 1 month and 6 months
• clinical course
• complications
• intestinal absorptive function
• respiratory function
• neurology (IVH)

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Patient Death Form K

• Cause of death
• ?related to NEC
• hospital stay
• recurrent NEC?
• complications?
• Follow up data

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Contact details

• ? 44 20 7829 7830
• ? 44 20 7905 2254
• ? Institute of Child Health, 30 Guilford St,
  London, WC1N 1EH
• ? nettrial_at_ich.ucl.ac.uk
• ? www.nettrial.net

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Thank you