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evdience based management of nec


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Lecture for dr Alaa Eldemerdash ()in short, during Port said third neonatology conference, 18 & 19 October 2012. Dubai health authority

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evdience based management of nec

  1. 1. Evidence-BasedManagement of NEC Alaa Eldemerdash, MD, FAAP Consultant and Head of Neonatology Latifa ( formerlyAl Wasl) Hospital, Dubai, UAE
  2. 2. QuestionDo you Use evidence in your management of NEC?Yes
  3. 3. What are the types of Evidence? Textbooks Learned it from my professor Conferences My own experience What we did in residency Published studies Others
  4. 4. Evidence Pyramid Type of Study Meta-Analysis Systematic Review Randomized Controlled Trial Cohort studies Case Control studies Case Series/Case Reports Expert Opinion/ Animal research
  5. 5. generation synthesis policy application 5 decisions 4 2 3 1 Knowledge Translation Steps from evidence generation to clinical application1. generation of evidence from research; 2. evidence summary and synthesis; 3.forming clinical policy; 4. application of policy; 5. individual clinical decisions, includinga) patient’s circumstances, b) patient’s wishes, and c) evidence
  6. 6. Level of Evidence and Grades ofRecommendationUSPSTF: United States Preventive Services Task ForceSORT: Strength of Recommendation TaxonomyCEBM: Center for Evidence Based MedicineGRADE systemMany others
  7. 7. CEBM: Levels of Evidence (LOE) Therapy/Prevention Prognosis Diagnosis DDx/ Symptom Economic and Etiology/Harm prevalence Decision analysis1a SR (with homogeneity) of RCTs1b RCT with narrow CI1c All or none2a SR (with homogeneity) of cohort studies2b Individual cohort study or low quality RCT2c “Outcomes” research3a SR (with homogeneity) case control studies3b Individual case-control study4 Case series/low quality cohort and case-control5 Expert opinion/bench research
  8. 8. CEBM: Grades of Recommendation (GOR)Used to grade a clinical recommendation based on a body of evidence:A: consistent Level 1 studiesB: consistent Level 2 or 3 studies, or extrapolation from Level 1 studiesC: Level 4 studies, or extrapolation from Level 2 or 3 studiesD: Level 5 studies, or troublingly inconsistent or inconclusive studies from any level
  9. 9. GRADE System: Individual StudiesUses four tiers for grading quality of evidence in a study for a particular outcome…High: further research unlikely to change our certainty or the effect sizeModerate: further research is likely to change our certainty and perhaps the effect sizeLow: further research likely to change our certainty and our estimate of the effect sizeVery low: estimate of effect is uncertain
  10. 10. GRADE System: Individual StudiesStart: RCT=3, observational study=1, other evidence=0Subtract: -1 or -2 for quality problems, -1 for reporting bias, -1 for sparse data, -1 or -2 for problems with applicability, etc.Add: +1 for evidence of dose response effect, +1 if plausible co- founders should have been in opposite direction, +1 or +2 for evidence of “association,” etc.
  11. 11. Pediatrics 2009;124;205-210
  12. 12. METHODSA retrospective analysis was conducted on VLBW infants (birth weight less than 1500 g) managed at 2 institutionsThe NICUs at both institutions follow an identical strategy for respiratory management of VLBW infants
  13. 13. Risk factors for NEC
  14. 14. ConclusionAuthors’ Conclusion:Initial respiratory support with ENCPAP seems to be a safe alternative to routine intubation and mechanical ventilation in premature infants
  15. 15. Formula milk versus maternal breast milk for feeding preterm or low birth weight infants Ginny Henderson, Mary Y Anthony, William McGuireCochrane Database of Systematic Reviews, Issue 4, 2009
  16. 16. Authors’ conclusionsThere are no data from randomised trials of formula milk versus maternal breast milk for feeding preterm or low birth weight infants.
  17. 17. Prevention of NECBreast milkTrophic feedsAdvancing feedsUse of H2 BlockersArginine and Glutamine supplementationOral AntibioticsOral IVIGProbiotics
  18. 18. H2 Blockers and NEC Ronnie Guillet, MD, PhDa, Barbara J. Stoll, MDb, C. Michael Cotten, MDc, Marie Gantz, PhDd, Scott McDonald, BSd,W. Kenneth Poole, PhDd, Dale L. Phelps, MDa, for members of the National Institute of Child Health and Human Development Neonatal Research Network PEDIATRICS Volume 117, Number 2, February 2006 Case-control study was conducted, and the results were analyzed with conditional logistic regression. Infants of 401 to 1500 g in birth weight who were cared for in 1 of the 19 (NICHD) Neonatal Research Network centers from September1998 to December 2001.
  19. 19. H2 Blockers and NECThree controls were matched to each NEC case on the basis of birth-weight category (401–750, 751–1000, 1001–1250,and 1251–1500 g), race , and center.Either enteral or parenteral ranitidine (Zantac), famotidine (Pepcid), or cimetidine (Tagamet) before 120 days of age, death, or discharge.
  20. 20. Ranitidine is Associated With Infections,Necrotizing Enterocolitis, and Fatal Outcomein NewbornsNewborns with birth weight ranging between 401 and 1500 g or gestational age between 24 and 32 weeks, consecutively observed in 4 Italian NICUs MEAP 2012 Terrin et al Pediatrics 2012;129;e40
  21. 21. Strategies for Prevention of NecrotizingEnterocolitis.
  22. 22. SummaryMeta-analysis and RCTs are best evidence ( sometimes not possible)Look at other important outcomesLook at guidelines and analysis in secondary publications and EBM organizations