Transcript NEC Study data entry presentation

UK Neonatal Collaborative
Necrotising Enterocolitis (UKNC-NEC)
Study
Data requirements
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
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
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
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)
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
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”
AIM 3: Enteral-feed related antecedents of NEC
Hypothesis: “There is an association between enteralfeed 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
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 milk
4) 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 formula
8) Nil by mouth
STUDY DATA REQUIREMENTS
Neonatal.Net
Types of data
“Once only”
data
(eg birthweight,
gestational
age)
Daily data
(eg feeds,
ventilation)
National
Neonatal
Research
Database
“Only if”
data
(eg infection,
AXR)
EPISODIC/ “ONLY IF” DATA ITEM
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
Episodic data: Abdominal x-ray performed ad-hoc form
Click under
“Ad-Hoc Event
Forms”
Abdominal x-ray performed ad-hoc form
If x-ray is not taken to
investigate abdominal
signs, the rest of the form
does not need to be
completed
Please discuss these with
a senior clinician of the
team. The consensus
team decision should then
be entered.
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.
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 notes
3. Enter the
information onto
Neonatal.Net at a
later time if you
are busy
“Reminders”
Before
discharge:
Please
ensure that all
incomplete
forms under
“Reminders”
are completed
Once
abdominal
x-ray form
saved and
closed, a
reminder to
complete the
outcome on
the form
appears on
patient home
page
Click form under “Reminders” to complete outcome
Whether
baby has
been
transferred
to another
unit
Surgical
outcome
Whether NEC
was confirmed
visually or
histologically
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.
VIEWING INDIVIDUAL COMPLETED AD-HOC
FORMS
Change page by clicking on
patient data tab
Click on Daily data to find
previously entered details on
ad-hoc form
Double click on the
displayed Abdominal Xray performed
information to open
the form
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
DAILY DATA ITEMS
DAILY DATA : WEIGHT
Daily/ Most
recent
weight is
needed to
calculate
daily
ml/kg/day
feeds
Daily feeding data: Type, Volume
Type of milk
feed given
to baby.
Able to tick
more than
one
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.
PACKED RED CELL TRANSFUSIONS
UMBILICAL ARTERIAL LINE
MEDICATIONS: COX-INHIBITORS, ANTIBIOTICS
STATIC/ “ONCE ONLY” DATA ITEMS
STATIC DATA: SEX, BIRTH WEIGHT, GESTATION
GASTROINTESTINAL ABNORMALITIES
Admission
Record GI
anomalies
in any/all
of these 3
places
Clinical
Summary of
Stay
Discharge
MOTHER’S ETHNICITY
ANTENATAL STEROIDS
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
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