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UK Neonatal Collaborative Necrotising Enterocolitis (UKNC-NEC) Study

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Presentation on theme: "UK Neonatal Collaborative Necrotising Enterocolitis (UKNC-NEC) Study"— Presentation transcript:

1 UK Neonatal Collaborative Necrotising Enterocolitis (UKNC-NEC) Study
4/19/2017 UK Neonatal Collaborative Necrotising Enterocolitis (UKNC-NEC) Study Data requirements

2 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 Key points: NEC is a devastating disease which is becoming a growing problem on our neonatal units. With improving survival of preterm infants, the population of babies at risk of developing NEC is increasing Approximately affects up to. 10% of very low birth weight babies but the exact UK figures are unknown Longterm complications include neurodevelopmental delay, gastrointestinal PN-associated cholestasis, liver failure, and short bowel syndrome

3 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 Key points: However, a few fundamental first steps need to be taken in an observational study to address gaps in the knowledge- Using a population approach This will provide data to develop a case-definition for NEC which is currently lacking,, Variations in case definition across studies invalidates comparative analyses, makes it difficult to pool data, and to use “NEC” as an outcome in clinical trials. -current enteral feeding practices across a geographically –defined area.- differs widely across even this country- when we feed, type of feed and how fast we increase feeds Estimate the baseline incidence rate of NEC and systematic surveillance

4 Aims To determine the population incidence of NEC in England
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

5 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) NIHR- National Institute of Health Research Medicines for neonates programme aims to utilise routine neonatal electronic records for research. CRN = clinical research network Number of units as at 22/02/2012

6 Method Analyse data collected from ALL babies admitted to participating neonatal units over an 18 month period November May 2013 Dependent on the quality of data Interim analyses on data completeness will be performed and fed back to units Data collected by you over an 18 month period will be analysed

7 Data Analysis Report by network using established case-definition
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” The population incidence will be reported by network and therefore complete network participation is encouraged. Cases of NEC will be identified using a case-defintiion developed as part of this study

8 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 For the third aim, The outcome of NEC or no NEC will be compared between groups of patients with diff enteral-feed explosures using the case-definition A selection of statistical methods including propensity score will be used

9 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 The different enteral-feed exposures include days to first feed, type of first feed, rate of advancement of feeds and summary measure of type of feed up to development of NEC

10 STUDY DATA REQUIREMENTS
Neonatal.Net

11 Types of data National Neonatal Research Database Daily data (eg feeds, ventilation) “Once only” data (eg birthweight, gestational age) “Only if” data (eg infection, AXR) Different types of data you enter feed into the NNRD which is a national resource . The quality of this database very much depends on the data entered by yourselves, clinicians and staff involved in the baby’s care.

12 EPISODIC/ “ONLY IF” DATA ITEM

13 Episodic/ “Only if” data
4/19/2017 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 A crucial data requirement for the study are signs and symptoms of babies with abdominal problems and their outcomes. These are captured on the Abdominal x-ray performed ad-hoc form. Please remember to fill in one of these forms when you after you either Have performed or reviewed an abdominal x-ray which has been done to investigate abdominal signs. This is regardless of the working diagnosis Both positive and negative findings are important to establish the case-definition.

14 Episodic data: Abdominal x-ray performed ad-hoc form
You will find the abdominal xray form under “Ad-hoc Event Forms” on the patient home page. Click under “Ad-Hoc Event Forms”

15 Abdominal x-ray performed ad-hoc form
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. 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. The form is very simple to fill in and please fill in details recorded close to the time of the x-ray being performed. This is to minimse bias. Complete the time and date of abdominal x-ray Whether it has been done to investigate abdominal signs- if it has been done for line positioning for e.g. , then the rest of the form does not need to be filled in. Whether the x-ray was done at this hospital /other- This highlights the importance of entering all x-rays which have been reviewed even if performed in another hospital. Babies transferred to another unit for surgical care may not have repeat xrays performed before surgery. Firstly, this allows entry of the outcome below and Secondly, interpretation of the x-ray may differ from the sending hospital. The rest of the form should be filled in after discussion with a senior member of the team (preferably consultant) and consensus team opinion entered. : Whether you think baby has NEC/ xray findings and clinical signs. Please then save and close .

16 Labels to improve data capture: ¼ A4 size to stick in notes
Complete a label after an abdominal x-ray has been reviewed Stick in the notes Enter the information onto Neonatal.Net at a later time if you are busy Sometimes computers are busy/ you cant find a senior to discuss findings or you are just too busy. To help capture data, these labels are being used. You will find these labels ________ on the unit. Please complete one of these soon after an abdominal x-ray has been performed or reviewed. Stick this in the notes and discuss with seniors if needed. Once the data is entered onto SEND/ neonatal.net / Badger, please tick the box that you have entered this information. The night team/day ward round team will be responsible for ensuring that all these boxes are ticked on a daily basis.

17 “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 Once you save and close a form which does not have outcome entered, a reminder will appear on the patient home page to complete the form once outcome is known.

18 Click form under “Reminders” to complete outcome
Whether baby has been transferred to another unit Surgical outcome Whether NEC was confirmed visually or histologically When the outcome is known, please then click on that reminder tab and complete the outcome. Please could all colleagues complete discharge letters, check on the home page to make sure all the incomplete form under “Reminders” are filled in.

19 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. If the baby died, please complete the “General discharge details form”. Please remember to return to complete post mortem details when available. This will usually be done by a consultant who receives the report.

20 VIEWING INDIVIDUAL COMPLETED AD-HOC FORMS
You may wish to view completed ad-hoc forms for individual patients to check the information on it. Your unit should have the facility to check all ad-hoc forms completed between certain dates on the unit

21 Change page by clicking on patient data tab
Click on Daily data to find previously entered details on ad-hoc form Go to patient data, then daily data

22 Click on Day of performance of abdominal x-ray
Double click on the displayed Abdominal X-ray 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

23 DAILY DATA ITEMS

24 Daily/ Most recent weight is needed to calculate daily ml/kg/day feeds
DAILY DATA : WEIGHT Daily/ Most recent weight is needed to calculate daily ml/kg/day feeds

25 Daily feeding data: Type, Volume
Type of milk feed given to baby. Able to tick more than one

26 Daily feeding data: Time of first feed , Type, Volume
If formula is ticked, please select from drop down list, the name of the formula Please make sure that the volume is ml not ml/kg/day , and not the amount PRESCRIBED. It should be entered only after a 24 hour period as it is the amount of milk GIVEN to the baby after 24 hours. 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.

27 PACKED RED CELL TRANSFUSIONS
Daily data

28 UMBILICAL ARTERIAL LINE

29 MEDICATIONS: COX-INHIBITORS, ANTIBIOTICS

30

31 STATIC/ “ONCE ONLY” DATA ITEMS

32 STATIC DATA: SEX, BIRTH WEIGHT, GESTATION

33 GASTROINTESTINAL ABNORMALITIES
Admission Record GI anomalies in any/all of these 3 places Clinical Summary of Stay Discharge diagnosis Discharge

34 MOTHER’S ETHNICITY

35 ANTENATAL STEROIDS

36 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 In summary, we all worry about NEC, when and what to feed, how fast, this is a chance we could collectively do something about it , using national resource to help answer some questions. Collaborative efforts in collecting high quality routine data can provide population-based data , which can be used for research purposes as well as your day-to day clinical uses. Integrating both clinical and research processes. . we have been approached by neonatal surgeons and neonatologists to address surgical related issues We are currently collaborating with the East of England network to evaluate the effect of a care bundle designed to reduce NEC. The routine electronic data is being used for analysis and data agreement studies are being conducted We look forward future collaborations. Exemplar study, if we can demonstrate that we can use routine data for research purposes, future colllaborative studies are possible

37 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


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