Infant Mortality Summit

Quality Improvement ProjectPlacental Transfusion

The Women’s Hospital, Newburgh, IN

Beth Durham, MSN, RNC-NIC

Severe IVH & NEC Frequent in Lowest Birth Weights

< 501

501-600

601-700

701-800

801-900

901-1000

1001-

1100

1101-

1200

1201-

1300

1301-

1400

> 1400

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

Severe IVH (VON, 2012)

Birth Weight

< 501

501-600

601-700

701-800

801-900

901-1000

1001-

1100

1101-

1200

1201-

1300

1301-

1400

> 1400

0.00%

2.00%

4.00%

6.00%

8.00%

10.00%

12.00%

NEC (VON, 2012)

Birth Weight

Severe IVH = Grade III + Grade IV

• Grade III– Blood in ventricle– Enlarged ventricle

• Grade IV– Blood in brain– (Not germinal matrix)

Cranial Ultrasound – Grade III

Grade III

Normal

Cranial Ultrasound – Grade IV

Normal

Grade IV

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

Prognosis of Grade III & IV IVH

Two year follow up:

• Developmental delay (DQ < 70) 17.5% • Cerebral Palsy

30.0%• Deafness 8.6%• Blindness 2.2%

Bolisetty, S et al Pediatrics. 2014 Jan;133(1):55-62.N = 93

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.

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.

Quality Improvement

Involves a change in behavior.Involves measurement.

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.

Quality Improvement (QI)

…requires measurements.

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

PDSA

Series of Large Projects Each Project Has Many Steps

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

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.

Present TWH NICU QI Project

Placental Transfusion ProjectPTP

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

Placental Transfusion Project

Timeline– May 2013 Presentation of ACOG/AAP opinion

statement at Soc. for Ped. Research– June 2013 Circulate supporting references at

TWH to Neo and Perinatal staffs. Begin Neo/Perinatal project meetings.

Began informal cord milking (no data).– July 2013 Introduce placental transfusion to

IVON QC as potential new project.• Potential for multiple site involvement in QI

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

Placental Transfusion Project

Timeline– Aug. 2013 First draft of NICU audit tool.

• Ped/OB collaboration on cord clamping & milking• OBs: We thought you wanted the baby ASAP…

– Nov. 2013 Grant 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. 2013 TWH OB protocol, parallel to IU.– Jan. 2014 Begin monthly data reporting to OB’s

• Continue PDSA cycles, create “run charts”, etc…

“Huddle Board”

Placental Transfusion ProjectTimeline– Feb. 2014 “Huddle Board” poster for NICU

(Monthly data reporting continued.)

– Mar. 2014 Dept. of Health approved $100,000grant for IVON QC project.

– May 2014 IU IRB approved IVON QC project.(8 participating NICUs)

– Sept. 2014 TWH data now statistically significant– Oct. 2014 TWH data presentation – “internal”.– Nov. 2014 TWH data – “external” report to state

“Infant Mortality Summit”.

Tracking Data• Data collection is part of QI• Data quality is important• Data trends are important

Labor Audit Tool

Labor Audit Tool

NICU Audit Tool

NICU Audit Tool

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

Placental Transfusion Procedures

Severe IVH

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?

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

Multiple Site Data Collection

• Multiple participating NICUs• REDCap data collection– Remote Electronic Data Capture software• Timed cord clamping• Cord milking• Exchange transfusion

Including 8 IU IRB Sites

REDCap Data Gathering Begins

Questions?

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