1) The document discusses different types of evidence used in managing NEC, including textbooks, experience, published studies, and guidelines. Higher levels of evidence include systematic reviews and randomized controlled trials. 2) Factors that can help or hinder the development of NEC are discussed, such as breast milk, feeding strategies, and supplements like arginine and glutamine. Studies have looked at whether interventions like H2 blockers or probiotics can prevent NEC. 3) The best evidence for managing NEC comes from meta-analyses, randomized trials, and guidelines, but these are not always possible. It is important to consider other outcomes in addition to NEC.

1. Evidence-Based
Management of NEC
Alaa Eldemerdash, MD, FAAP
Consultant and Head of Neonatology
Latifa ( formerlyAl Wasl) Hospital, Dubai, UAE

2. Question
Do you Use evidence in your management of NEC?
Yes

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. 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. generation synthesis policy application 5
decisions
4
2 3
1
Knowledge Translation
Steps from evidence generation to clinical application
1. generation of evidence from research; 2. evidence summary and synthesis; 3.
forming clinical policy; 4. application of policy; 5. individual clinical decisions, including
a) patient’s circumstances, b) patient’s wishes, and c) evidence

6. Level of Evidence and Grades of
Recommendation
USPSTF: United States Preventive Services Task Force
SORT: Strength of Recommendation Taxonomy
CEBM: Center for Evidence Based Medicine
GRADE system
Many others

7. CEBM: Levels of Evidence (LOE)
Therapy/Prevention Prognosis Diagnosis DDx/ Symptom Economic and
Etiology/Harm prevalence Decision analysis
1a SR (with homogeneity)
of RCTs
1b RCT with narrow CI
1c All or none
2a SR (with homogeneity)
of cohort studies
2b Individual cohort study
or low quality RCT
2c “Outcomes” research
3a SR (with homogeneity)
case control studies
3b Individual case-control
study
4 Case series/low quality
cohort and case-control
5 Expert opinion/bench
research

8. CEBM: Grades of Recommendation (GOR)
Used to grade a clinical recommendation based on a body of
evidence:
A: consistent Level 1 studies
B: consistent Level 2 or 3 studies, or extrapolation from Level
1 studies
C: Level 4 studies, or extrapolation from Level 2 or 3 studies
D: Level 5 studies, or troublingly inconsistent or inconclusive
studies from any level

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. 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. Pediatrics 2009;124;205-210

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. Risk factors for NEC

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. 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. 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. Prevention of NEC
Breast milk
Trophic feeds
Advancing feeds
Use of H2 Blockers
Arginine and Glutamine supplementation
Oral Antibiotics
Oral IVIG
Probiotics

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. 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. Ranitidine is Associated With Infections,
Necrotizing Enterocolitis, and Fatal Outcome
in 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. Strategies for Prevention of Necrotizing
Enterocolitis.

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