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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 )

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UK Neonatal Collaborative Necrotising Enterocolitis (UKNC-NEC) Study

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  1. 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

  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

  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)

  6. 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

  7. 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”

  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

  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

  10. STUDY DATA REQUIREMENTS Neonatal.Net

  11. Types of data

  12. EPISODIC/ “ONLY IF” DATA ITEM

  13. 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

  14. Episodic data: Abdominal x-ray performed ad-hoc form 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.

  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

  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

  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

  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.

  20. VIEWING INDIVIDUAL COMPLETED AD-HOC FORMS

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

  22. 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 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 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

  28. UMBILICAL ARTERIAL LINE

  29. MEDICATIONS: COX-INHIBITORS, ANTIBIOTICS

  30. STATIC/ “ONCE ONLY” DATA ITEMS

  31. STATIC DATA: SEX, BIRTH WEIGHT, GESTATION

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

  33. MOTHER’S ETHNICITY

  34. ANTENATAL STEROIDS

  35. 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

  36. 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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