1. Infant Mortality Summit Quality Improvement Project Placental Transfusion The Women’s Hospital, Newburgh, IN Beth Durham, MSN, RNC-NIC

3. Severe IVH & NEC Frequent in Lowest Birth Weights

4. Severe IVH = Grade III + Grade IV Grade III – Blood in ventricle – Enlarged ventricle Grade IV – Blood in brain – (Not germinal matrix)

5. Cranial Ultrasound – Grade III Grade III Normal

6. Cranial Ultrasound – Grade IV Normal Grade IV

7. Prognosis of Grade III IVH Five year follow up: ¼ Normal ¼ Mild Neurological Symptoms ¼ Moderate Handicap or Retardation ¼ Severe Handicap or Severe Retardation Resch B Childs Nerv Syst 1996 Jan;12(1):27-33 N = 40

8. Prognosis of Grade III & IV IVH Two year follow up: Developmental delay (DQ < 70) 17.5% Cerebral Palsy30.0% Deafness 8.6% Blindness 2.2% Bolisetty, S et al Pediatrics. 2014 Jan;133(1):55-62. N = 93

9. Cord Clamping, Then and Now 1950’s “Early Clamping” – If before 60 sec “Late Clamping” – If after 5 minutes. Now“Immediate Clamping” Usually 15 – 20 seconds after delivery “Delayed Clamping” – 30 to 60 sec.

10. Timed Cord Clamping Transfer of 15 mL/Kg of blood after 1 minute from placenta to baby. Increase blood volume from 70 to 85 ml/kg at birth by not immediately clamping the cord. Transfer of 20 mL/Kg of blood after 3 minutes.

11. Quality Improvement Involves a change in behavior. Involves measurement.

12. William Edwards Deming 1900 – 1993 "PDSA" (Plan-Do-Study-Act). A number of Japanese manufacturers applied his techniques widely and experienced heretofore unheard-of levels of quality and productivity.

13. Quality Improvement (QI) …requires measurements.

14. Research v. QI Research – Fixed study design – Focus on one question – May not produce result – May not lead to quality improvement Quality Improvement – Focus on outcome measurements – Flexible study design – Focus of study may shift – PDSA cycles designed to lead to improvement

15. PDSA Series of Large ProjectsEach Project Has Many Steps

16. ACOG & AAP Agree - December 2012 Placental Transfusion Reduces IVH Benefits for premature – Reduce IVH by 50% – Improved transitional circulation – Improved blood volume – Decreased need for transfusions

17. Placental Transfusion Reduces NEC AUTHORS' CONCLUSIONS: Providing additional placental blood to the preterm baby by delaying cord clamping for 30 to 120 seconds, rather than early clamping, seems to be associated with less need for transfusion, better circulatory stability, less intraventricular hemorrhage (all grades) and lower risk for necrotizing enterocolitis. Cochrane Database Syst Rev. 2012 Aug 15;8:CD003248. doi:10.1002/14651858.CD003248.pub3.

18. Present TWH NICU QI Project

19. Placental Transfusion Project PTP A transfusion of blood from the placenta to the premature infant at delivery reduces the incidence of severe IVH and NEC. --- Implementation of ACOG-AAP Consensus

20. Placental Transfusion Project Timeline – May 2013Presentation of ACOG/AAP opinion statement at Soc. for Ped. Research – June 2013Circulate supporting references at TWH to Neo and Perinatal staffs. Begin Neo/Perinatal project meetings. Began informal cord milking (no data). – July 2013Introduce placental transfusion to IVON QC as potential new project. Potential for multiple site involvement in QI

21. Placental Transfusion Project Fundamentally different from earlier projects – Multiple departments OBs and Peds – Data set not captured by NeoData (NICU EMR) Need new form of data capture and tracking

22. Placental Transfusion Project Timeline – Aug. 2013First draft of NICU audit tool. Ped/OB collaboration on cord clamping & milking OBs: We thought you wanted the baby ASAP… – Nov. 2013Grant proposal submitted to Indiana Department of Health for I-VON QC – Nov. 2013 TWH NICU data collection begins. Project staff meetings begin in earnest. – Dec. 2013TWH OB protocol, parallel to IU. – Jan. 2014Begin monthly data reporting to OB’s Continue PDSA cycles, create “run charts”, etc…

23. “Huddle Board”

24. Placental Transfusion Project Timeline – Feb. 2014“Huddle Board” poster for NICU (Monthly data reporting continued.) – Mar. 2014Dept. of Health approved $100,000 grant for IVON QCproject. – May 2014IU IRB approved IVON QC project. (8 participating NICUs) – Sept. 2014TWH data now statistically significant – Oct. 2014TWH data presentation – “internal”. – Nov. 2014TWH data – “external” report to state “Infant Mortality Summit”.

25. Tracking Data Data collection is part of QI Data quality is important Data trends are important

26. Labor Audit Tool

28. NICU Audit Tool

29. # NICU Audit Tools Submitted Audit Tool Submission Rate (%)

30. Placental Transfusion Procedures

31. Severe IVH

32. No Severe IVH Last IVH event was in May 2013, before starting our project… The reduction in IVH in 2013 + 2014 is statistically significant, P<.05, but… …could it just be by chance?

33. Improvement v. Random Event Weakness of relatively sample sizes – Just “lucky” so far…? – Gather more data slowly Years of data necessary for infrequent events Gather larger sample size quickly – Placental Transfusion Project at 8 sites – Multiple NICU participation yields more data Project data gathering begins October 2014

34. Multiple Site Data Collection Multiple participating NICUs REDCap data collection – Remote Electronic Data Capture software Timed cord clamping Cord milking Exchange transfusion

35. Including 8 IU IRB Sites

36. REDCap Data Gathering Begins

37. Questions? Thank you to Dr. Kenneth Herrmann for your help with this presentation.