clinical safety & effectiveness cohort #17
TRANSCRIPT
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Clinical Safety & EffectivenessCohort #17
Delayed Cord Clamping
Team 7
DATE
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The Team– Amy Quinn MD– Margarita Vasquez MD – Michael Sorrell DO– Richard Stribley MD– Sartaj Siddiqui DO– Patrick Ramsey MD– Kayla Ireland MD– Adriana Perez– Melanie Baker
– Irma Sanchez– Rachel Farner– Rachel Rivas– Irene Sandate– Iba Aburizik
Sponsor Department: Department of Pediatrics, Division of Neonatology, Dr. Steven Seidner
Team Picture
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History of Cord Clamping
• 1790 – Erasmus Darwin – “Another thing very injurious to the child is the tying and
cutting of the navel string too soon, which should always be left till the child has not only repeatedly breathed but till all pulsation in the cord ceases. As otherwise the child is much weaker than it ought to be, a part of the blood being left in the placenta which ought to have been in the child and at the same time the placenta does not so naturally collapse, and withdraw itself from the sides of the uterus, and is not therefore removed with so much safety and certainty.”
History of Cord Clamping
• Mid 20th Century– Cord clamping begins to occur earlier– Theories
• More women delivering in hospitals• More obstetricians conducting deliveries• An increasing number of surgical deliveries
• 1960s - Active Management of Third Stage of Labor– The overall goal of preventing maternal postpartum hemorrhage
• Administration of a prophylactic uterotonic agent• Clamping and cutting the umbilical cord shortly after birth• Controlled cord traction of the umbilical cord
Early Cord Clamping
• Over a period of several years in the 60s and with relatively minimal scientific evidence of benefit, ECC became the norm
• DCC was “discarded from mainstream practice without careful study or regard to the physiologic processes at work.”
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Aim Statement
We aim to achieve 50% implementation of a delayed cord clamping protocol at University Hospital in our target preterm neonate population by December 1st, 2015.
Clinical Benefits• Intraventricular Hemorrhage
– For every 100 babies who undergo delayed cord clamping < 37 weeks:
• Approximately 7-9 cases of IVH will be prevented • Approximately 22 cases of IVH will be prevented if only babies
< 32 weeks are considered• Mean Blood Pressure/Need for Inotropic Support
– Mean arterial blood pressures significantly improved at birth and at 4 hours of life with delayed cord clamping
– Less inotropic support required with DCC (Rabe et al) • Early cord clamping – 22 patients • Delayed cord clamping – 9 patients
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Clinical Benefits
• Blood Transfusions– For every 100 patients who receive DCC:
• 26-33 babies will be spared at least one subsequent blood transfusion
• Up to 45 babies spared transfusion in one study (Kinmond et al.); these patients were of a younger gestational age and on ventilators
• Admission Hematocrit: Higher with DCC– Initial Hematocrit: DCC – 51%, ECC – 46%– Hematocrit at 24hrs of life: DCC – 55%, ECC – 51%
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Clinical Benefits
• Rates of sepsis significantly LOWER in children who undergo delayed cord clamping – Potentially due to increased transfer of maternal
immunoglobulins, or stem cells
• Total NEC events LESS when patients underwent delayed cord clamping:– Early cord clamping – 39 NEC events– Delayed cord clamping – 24 NEC events
The potential for harm needs to be weighed by clinicians in context within the settings in
which they work
Safety Concerns
• Primary safety concerns have been addressed in literature extensively in multiple studies totaling over 4,000 randomized neonates
• No difference in:– APGARs– Admission Temperature– Need for phototherapy– Need for an exchange transfusion
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Current Position
• Basic Newborn Resuscitation Guideline 2012• “In newly-born term babies who do not require positive-
pressure ventilation, the cord should not be clamped earlier than one minute after birth”
• Strong recommendation based on evidence of high to moderate quality
• WHO Recommendations for the prevention of postpartum haemorrhage state that the cord should not be clamped earlier than is necessary for applying cord traction (around 3 minutes)
Kim et al., Neoreviews, 2015
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Project Milestones
• Team Created August 2015• AIM statement created August 2015• Weekly Team Meetings Aug to Dec 2105• Background Data, Brainstorm Sessions, Sept 2015
Workflow and Fishbone Analyses• Interventions Implemented Oct 5th, 2015• Data Analysis Dec 2015• CS&E Presentation Jan 2016
Cord Clamping Process Evaluation
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Process Evaluation
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PLAN: Intervention
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PLAN: Intervention
DO: Implementation
• Developed the intervention flow sheet and data collection form in early August
• Started teaching NICU and L&D nurses in FYI weekly meetings mid August
• Informing and teaching faculty and fellows in morning report meetings in September
• Implementation of delayed cord clamping occurred October 1, 2015
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CHECK: RESULTS/IMPACT
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Cord Clamping DelayedPost-Intervention
Yes71%
No29%
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UCL 1.0
0.0
CL 0.20.0
LCL -0.6
0.0
-1.0
-0.5
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
num
ber o
f pRB
Cs
Date of birth
Number of pRBC Transfusions in First 7 Days of Life
Intervention
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UCL 68.765.6
CL 45.7
50.7
LCL 22.6
35.8
15.0
25.0
35.0
45.0
55.0
65.0
75.0
HCT
-ini
tial
Date of birth
Initial Hematocrit
Intervention
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UCL 72.3 71.7
CL 43.745.6
LCL 15.1
19.6
5.6
15.6
25.6
35.6
45.6
55.6
65.6
75.6
85.6
MAP
Adm
it
Date of birth
Mean Arterial Pressure at Admission
Intervention
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UCL 99.83
98.79
CL 97.9997.80
LCL 96.15
96.80
95.3
95.8
96.3
96.8
97.3
97.8
98.3
98.8
99.3
99.8
100.3
Adm
issi
on te
mp
Date of birth
Admission Temperature
Intervention
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UCL 12.6
11.0
CL 7.27.5
LCL 1.9
4.0
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
1 m
in A
pgar
Date of birth
One Minute Apgar
Intervention
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UCL 11.3 11.1
CL 8.18.3
LCL 5.0
5.5
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
11.0
12.0
5 m
in A
pgar
Date of birth
Five Minute Apgar
Intervention
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UCL 9.01
11.64
CL 4.90
6.10
LCL 0.78 0.56
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
Bilir
ubin
Date of birth
Peak Total Bilirubin in first 24 Hours of Life
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Return on Investment
• Both Measurable and immeasurable benefits exist in this study
• Improvements in communication between NICU and Labor and Delivery are a byproduct of DCC project
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Return on Investment
Direct Cost Savings:– Evidence estimates approximately 25-30
blood transfusion are prevented for every 100 premature infants who undergo DCC
– Each blood transfusion in the NICU costs approximately $900
– Each year, DCC is estimated to save the UHS NICU approximately $81,000
J Perinatol. 2015 Feb;35(2):132-6. doi: 10.1038/jp.2014.171. Epub 2014 Sep 25.
Lessons Learned
• Build a team of invested individuals and then involve team every step of the way
• Implementing a change in clinical practice will take much longer/will be much harder then you think
• Project success depends on gaining “Buy In” from nursing staff and administration
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ACT: Sustaining the Results
• Team will continue to refine clinical protocol to ensure sustained increase in rates of delayed cord clamping in appropriate patients by:– Continued education/training of medical staff – through
weekly “FYI” meetings with nursing staff, “Morning Report” of medical staff
– Continue to ensure adequate communication between NICU and OB teams
– Adjust protocol when necessary to suit delivery room environment
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Future Plans
• Once clinical protocol fully integrated into standard of care, plan is to expand target population
• In next 2-3 months, target population will be expanded to include infants 26 0/7 weeks and older
• Ultimate goal is to perform Delayed Cord Clamping on All premature infants born at University Hospital
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Thank you!
Questions?