uk neonatal collaborative necrotising enterocolitis (uknc-nec) study

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 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

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

STUDY DATA REQUIREMENTS

Neonatal.Net

Types of data

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”

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

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

“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

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

Click on Daily data to find previously entered details on

ad-hoc form

Change page by clicking on patient data tab

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

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

Record GI anomalies in any/all of these 3 places

Admission

Discharge

Clinical Summary of

Stay

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