pulse oximetry screening of newborns

www.childrensnational.org

Congenital Heart Disease Screening Program Implementing A Community Based Toolkit

Gerard R. Martin, MD

Elizabeth A. Bradshaw, RN

Joseph L. Wright, MD, MPH

This material is made possible by The Elsie and Marvin Dekelboum Family Foundation

Parent’s Perspective

“Over the eleven years since I started C.H.I.N., hardly a day goes by when I do not hear from a distraught

parent whose child was not diagnosed at birth, leading to tragic or serious life-long consequences.”

Mona Barmash, President of Children’s Heart Information Network

JCCHD Meeting, Fall 2007

Learning Objectives

♥ Identify need for screening for CHD in the nursery

♥ Discuss evidence-based recommendations for implementing screening in community hospitals

♥ Discuss efforts for dissemination on state or national levels

♥ Recognize the public health benefit of a population-based approach to best practice

A Question for the Group

Physical examination in the newborn nursery accurately detects critical

congenital heart disease?

a. TRUE

b. FALSE

Transitional Circulation

♥ Circulatory changes include:

- Increase in systemic vascular resistance

- Decrease in pulmonary vascular resistance

- Increase in left atrial pressure

- Closure of ductus arteriosus & foramen ovale

- Increase in left ventricular stroke volume

♥ Autonomic changes include:

- Hypersympathetic state

The Neonate with Suspected Heart Disease

Screening Principles

♥ Screening valuable if:– incidence is sufficient in the population

– therapy provided before onset of clinical manifestations results in an improved outcome

– screening identifies disease before symptoms

– test has acceptable sensitivity and false positive rates

– cost effective

Wilson and Junger WHO 1968 Public Health Paper

Newborns with CHD

♥ Congenital Heart Disease affects 5-10/1000 LB– the most common birth

defect

– incidence varies based

upon inclusion criteria

– 4/1000 require Rx

in the first year of lifeHoffman JACC 39:2002

Newborns with CHD

♥ CHD has significant morbidity/mortality

– nearly 40% deaths from congenital anomalies

– majority of deaths

occur among infants

Boneva Circ 103:2001

Newborns with CHD

♥ Timely recognition in NB period is critical– Prenatal diagnosis made in only 23% of pregnancies and

only 11% of live births

– In 39% (7/18) diagnosis only made at subsequent admission

Acharya ACTA Ob Gyn Scand 83:2004

Failure to Diagnose Critical CHD

Mellander Acta Paediatrica 95:200622/51 (43%) of late diagnosis

in shock on admission

Failure to Diagnose Critical CHD

Kuehl Peds 103:1999

Current Diagnosis/Detection

♥ Newborn screening programs exist

– cyanosis, auscultation, palpation of pulses

– results mostly unknown but detection may be < 50%

Wren in Arch Dis Child Fetal Neonatal Ed 80:1999

♥ 1 % Dead Pre-detection

♥ Only 44% had detection by PE alone

Pulse Oximetry Screening

Koppel Pediatrics 111:2003

Pulse Oximetry as Screening Method

♥ Pulse oximetry measures the amount of oxygen in the blood

♥ Non-invasive and painless test

Transitional Circulation

Passing Sat98%

Simple Transposition of the Great Arteries

Failing Sat65%

Hypoplastic Left Heart Syndrome

Failing Sat90%

Pulse Oximetry Screening

Thangaratinam Arch Dis Child Fetal Neonatal Med 92:2007

Highest Sensitivity

Highest Specificity in tests after 24 hours

Screening Principles

♥ Screening valuable if:– incidence is sufficient in the population

– therapy provided before onset of clinical manifestations results in an improved outcome

– screening identifies disease before symptoms

– test has acceptable sensitivity and false positive rates

– cost effective

Wilson and Junger WHO 1968 Public Health Paper

Why have we not done anything?

♥ Cardiologists have not been fully supportive of screening.

♥ Advocacy necessary.

Chang, Rodriguez & Klitzner, 2008

AHA/AAP Scientific Statement

♥ Purpose: Address evidence on the routine use of pulse oximetry in newborns to detect critical CHD

♥ Methods: Medline database searches from 1966-2008

♥ Analysis of pooled studies performed after 24 h life– Sensitivity 69.6%, PPV 47%– False positive screens requiring further testing 0.035%

AHA/AAP Scientific Statement

♥Conclusions:

-Critical CHD is not detected in some infants

-Failure to detect is associated with significant morbidity and occasional mortality

-Pulse oximetry may detect critical CHD

-Routine pulse oximetry after 24 hours incurs low cost and risk of harm

-Further studies in larger populations necessary across a broad range of newborn

delivery systems to decide whether this should be standard of care

European Efforts

Granelli BMJ 338:2009

European Efforts

Granelli BMJ 338:2009

♥ To address questions regarding implementation, partnership established Holy Cross Hospital in Silver Spring, Maryland, one of the areas busiest birthing facilities

♥ Evidence-based research protocol to examine implementation in community nurseries

♥ Enrollment of mothers and infants began January 12, 2009

Research Efforts Surrounding Implementation

Study Aims:

1. Determine if a pulse oximetry screening program for the detection of critical congenital heart disease can be implemented in a large community hospital.

2. Identify obstacles encountered while performing pulse oximetry screening methods of suggested screening program design..

3. Determine number of participants with critical congenital heart disease identified by suggested program design..

4. Evaluate the effectiveness of the maternal consent process for pulse oximetry screening of infants.

Implementing a screening program requires how many additional staff

positions?

Overview of Methods:

♥ Pox on right arm and right foot following 24 hours of age, in conjunction with PKU screen

♥ “Passing” Pulse Ox Sats – Greater than 95%

♥ “Referring” Pulse Ox Sats – Equal to or less than 95%, 3% Differential between RH and RF

- Pediatrician alerted. Echo and Cardiology Consult Recommended

♥ Tracking of enrolled infants actually screened, time of screening, obstacles to screening, maternal recall of consent

Preliminary Findings from Research Efforts:

• 6,705 infant participants enrolled

• 6,489infant participants (97%) actually screened

• 3 False Positives

• 2 Inconclusive – Primary MD did not order additional tests

• 4 True Positive

– 2 TP for Critical CHD (SVC draining to LA, Dextrocardia with Situs Inversus)

– 2 TP for Non-Critical CHD (Dilated Aorta, ASD)

• Screening time = Approximately 4 minutes per participant

• Average Pox Sat = 98-99%

• Obstacles to screening: High Volume Days, Early Discharges

• Approximately 90% of mothers are able to recall that they agreed to participate in the study and that their infant was screened

Congenital Heart Disease Screening Program

MissionThe Congenital Heart Disease Screening Program values

the early diagnosis of congenital heart disease in newborns prior to the clinical deterioration of affected infants. The program promotes early detection through the use of pulse oximetry following 24 hours of age and

prior to discharge from the newborn nursery. The program values the importance of the screening of all

healthy newborns for congenital heart disease.

VisionAll infants with critical congenital heart disease are

detected before leaving the newborn nursery.

CHDSP “Toolkit”Evidence-based materials for

implementation of Congenital

Heart Disease Screening Program

in academic and community

hospitals.

www.childrensnational.org/pulseox

www.childrensnational.org/Pulseox

Congenital Heart Disease Screening Program:States in Which Organizations Have Requested Toolkit

Washington Hospital Center

Holy Cross Hospital

Shady Grove Adventist Hospital

Mary Washington Healthcare

Stafford Hospital

Alexandria InovaHospital

Georgetown University Hospital

Sibley Memorial Hospital

Organizations Working to Implement CHDSP in Washington, DC Metro Area

Middle East

Hamad Medical

Adan Hospital

Ahmadi Hospital

Building Child Health Advocacy into an Academic Community-Based Intervention

Public Health Parable

A man is standing by a river when he hears a cry for help. He

sees someone struggling in the water, on the verge of drowning.

Being an expert swimmer, he jumps in and rescues the victim.

Before he has time to rejoice in his success, however, he sees

someone else floating by, also crying for help. As soon as he

rescues this person, he discovers a third....then a fourth and a

fifth. More and more victims float by, taxing his swimming

stamina. Finally he walks away. When asked where he is

going, he replies, "I'm going up the river to try to stop people

from falling in."

Getting Upstream…

……To Make A DifferenceTo Make A Difference

How many states have enacted legislation to mandate universal newborn screening

for congenital heart disease?

A) 0-1

B) 2-5

C) 6-10

D) >10

Population Medicine: A Public Health/Prevention Approach

““ UP

””IN

Clinical Enterprise:

Centers of Excellence

COLLABORATIVE IMPLEMENTATION

Building in Child Health Advocacy

• Why Advocacy?

– Community Benefit

– Corporate Compliance/Citizenship

• Collaborative Implementation

Broad Definition: Child Advocacy

• Engagement in activities that seek to compensate for the fundamental vulnerability of children.

Alfred J. Kahn, DSW Alfred J. Kahn, DSW Emeritus Professor Emeritus Professor Columbia University School Columbia University School of Social Workof Social Work

Action-Oriented Definition The Pediatrician Advocate

“To speak up, to plead or to champion for a cause

while applying professional expertise and leadership to support efforts on individual (patient or family), community, and legislative/policy levels, which result in the improved quality of life for individuals, families and communities.”

Ambulatory Pediatrics 2005;5:165

“Upstream” Strategies:

• Toolkit Development

• Professional Organizations

• NACHRI Webinar

• Legislative Advocacy

• Regulatory Solutions

Prevention ScienceA Tactical Approach – The 3 E’s

Engineering– Technological advance

– Cost effective

Education (multiple levels)– Professional

– Public

Enforcement– Best practice policy

– Regulation

– Legislation

The CHDSP InterventionApplying the 3 E’s

• Engineering– Technological advance

– Cost effective

• Education (multiple levels)

– Professional

– Public

• Enforcement– Best practice policy

– Regulation

– Legislation

Feasibility– Non-invasive, inexpensive screen

– Tele-echocardiography access

Awareness/Call to Action– Organized Medicine, e.g. AAP, ACC,

– Advocacy ‘landing page’ on website

Next Steps:– Elected officials and stakeholder briefings

– Identify & support champions

– Work with state regulators

“Innovating Strategies to Transform Children’s Health”

Questions?

Contact Information

Children’s National Heart InstituteGerard R. Martin, MD, FAAP, FACC

gmartin@cnmc.org

Elizabeth A. Bradshaw, MSN, RN, CPNebradsha@cnmc.org

Child Health Advocacy InstituteJoseph L. Wright, MD, MPH

jwright@cnmc.org

www.childrensnational.org/Pulseox

pulse oximetry screening of newborns

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