UK Neonatal Collaborative Necrotising Enterocolitis (UKNC-NEC) Study
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UK Neonatal Collaborative Necrotising Enterocolitis (UKNC-NEC) Study
Data requirements
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Necrotising Enterocolitis
Infant mortality in UK:
Overall ↓
NEC associated ↑ (Rees et al 2008)
Affects up to 10% of low birth weight babies
30-50% mortality (Lin and Stoll 2006)
Long-term complications (Stoll et al 2004)
Limited preventive and treatment strategies
Limited knowledge of risk factors beyond low
gestational age and birth weight
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Addressing the gaps
Current feeding practices and how this influences
susceptibility to NEC
An evidence-based case-definition for NEC used
consistently
Baseline incidence and systematic surveillance
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Aims
1) To determine the population incidence of NEC in England
2) To establish an objective case-definition for NEC
3) To identify enteral-feed related factors that precede onset of NEC in order to inform the design of future interventional randomised controlled trials
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UK Neonatal Collaborative NEC STUDY
NIHR funded
Medicines for Neonates Programme
CRN portfolio adopted study No 11853
153 (94% neonatal units in England:41 level 3; 68 level 2; 44 level 1)
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Method
Analyse data collected from ALL babies admitted to participating neonatal units over an 18 month period
November 2011- May 2013
Dependent on the quality of data
Interim analyses on data completeness will be performed and fed back to units
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Data Analysis
AIM 1: To determine the population incidence of NEC in England
Report by network using established case-definition
AIM 2: To establish an objective case-definition for NEC
Which best predicts the "gold-standard" confirmatory evidence of NEC:
“NEC on histology of resected bowel
OR visual inspection at laparotomy
OR visual inspection at post mortem examination”
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AIM 3: Enteral-feed related antecedents of NEC
Hypothesis: “There is an association between enteral-feed related factors and NEC”
Method: Comparing the outcome (NEC or no NEC) between groups of patients with different enteral-feed exposures
Statistical analysis: A selection of statistical methods to adjust for confounding factors
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Enteral-feed related exposures
Days (from birth) to first feed
Type of first feed (Maternal Expressed Breast Milk, Human Donor Milk, Formula)
Days to reach 120ml/kg/day
Summary measure of type of feed up to development of NEC: 1) Exclusive maternal breast milk 2) Maternal breast milk with breast milk fortifier 3) Exclusive human donor milk4) Human donor milk with breast milk fortifier 5) Exclusive formula 6) Mixed human (maternal or donor) milk 7) Mixed human (maternal or donor) milk and formula8) Nil by mouth
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STUDY DATA REQUIREMENTS
Neonatal.Net
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Types of data
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EPISODIC/ “ONLY IF” DATA ITEM
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Episodic/ “Only if” data
ABDOMINAL X-RAY PERFORMED AD-HOC FORM
TRIGGER to complete form=
Performing AND/OR Reviewing
Any abdominal x-ray performed to investigate abdominal signs
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Episodic data: Abdominal x-ray performed ad-hoc form
Click under “Ad-Hoc Event
Forms”
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If x-ray is not taken to investigate abdominal
signs, the rest of the form does not need to be
completed
Babies transferred between hospitals may not have
abdominal x-rays repeated in the receiving hospital. In
these cases, please complete a form after
reviewing abdominal x-rays taken in another hospital.
This then allows the outcome to be completed
later on.
Please discuss these with a senior clinician of the team. The consensus
team decision should then be entered.
Abdominal x-ray performed ad-hoc form
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Labels to improve data capture: ¼ A4 size to stick in notes
1. Complete a label after an abdominal x-ray has been reviewed
2. Stick in the notes3. Enter the
information onto Neonatal.Net at a later time if you are busy
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“Reminders”
Once abdominal x-ray form saved and closed, a
reminder to complete the outcome on
the form appears on
patient home page
Before discharge:
Please ensure that all
incomplete forms under “Reminders”
are completed
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Click form under “Reminders” to complete outcome
Whether baby has
been transferred to another
unit
Surgical outcome
Whether NEC was confirmed
visually or histologically
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If the baby died, complete the discharge/died form
Please remember to complete whether post mortem was performed and whether NEC was confirmed. The report will usually be sent to
the consultant.
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VIEWING INDIVIDUAL COMPLETED AD-HOC FORMS
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Click on Daily data to find previously entered details on
ad-hoc form
Change page by clicking on patient data tab
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A GREEN STAR will be next to the dates when ad-hoc events
have been entered. Click on Day of performance of
abdominal x-ray
Double click on the displayed Abdominal X-
ray performed information to open the
form
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DAILY DATA ITEMS
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DAILY DATA : WEIGHT
Daily/ Most recent
weight is needed to calculate
daily ml/kg/day
feeds
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Daily feeding data: Type, Volume
Type of milk feed given to baby.
Able to tick more than
one
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Daily feeding data: Time of first feed , Type, Volume
If formula is ticked, please
select from drop down
list, the name of the
formula
This is total measurable (i.e. not
applicable if fully breast fed) volume
of milk GIVEN to the baby after 24 hours
in ml, NOT ml/kg/day.
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PACKED RED CELL TRANSFUSIONS
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UMBILICAL ARTERIAL LINE
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MEDICATIONS: COX-INHIBITORS, ANTIBIOTICS
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STATIC/ “ONCE ONLY” DATA ITEMS
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STATIC DATA: SEX, BIRTH WEIGHT, GESTATION
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GASTROINTESTINAL ABNORMALITIES
Record GI anomalies in any/all of these 3 places
Admission
Discharge
Clinical Summary of
Stay
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MOTHER’S ETHNICITY
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ANTENATAL STEROIDS
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Summary
Data on Badger/SEND/Neonatal.Net is used for many
purposes: clinical service delivery, commissioning, audit and
research
Neonatal staff entering data are responsible for the quality-
That means YOU!
Please ensure complete and accurate data are entered
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THANK YOU
To: The UKNC–NEC Study Group: All staff in participating neonatal units
THANK YOU
FROM:
Investigators
Professor Neena Modi
Professor Kate Costeloe
Dr Cheryl Battersby
NDAU Steering Board
Jane Abbott (BLISS) Jacquie Kemp
Prof. Peter Brocklehurst Prof. Azeem Majeed
Prof. Kate Costeloe Prof. Neena Modi
Prof. Liz Draper Prof. Andrew Wilkinson