NEW YORK (Reuters Health) – Currently available evidence supports pulse oximetry screening of newborns for low blood oxygen saturation to detect critical congenital heart disease (CCHD), according to a new report.
The report, scheduled for online publication August 22nd in Pediatrics, outlines a strategy for implementing a national CCHD screening program.
New Jersey is already set to begin routine CCHD screening on August 31, becoming the first state to do so under a bill Gov. Chris Christie signed into law in June.
The recommendations appearing today in Pediatrics are from an expert working group convened by the U.S. Health and Human Services (HHS) Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), the American Academy of Pediatrics, the American College of Cardiology Foundation, and the American Heart Association.
Two years ago, in a July 2009 statement, the American Academy of Pediatrics and the American Heart Association concluded that there is strong evidence to support newborn screening of CCHD with pulse oximetry. The organizations also concluded that studies in larger populations and across a broad range of newborn delivery systems are needed to determine whether this practice should become standard of care in the routine assessment of the neonate.
In September 2010, the SACHDNC recommended adding critical congenital cyanotic heart disease to the recommended uniform newborn screening panel based on a review of the evidence. However, at that time, the Secretary of HHS felt it was premature to adopt such a policy pending development of strategies for implementing safe, effective and efficient screening.
The report published today is the culmination of an effort by Dr. Alex R. Kemper, of the Clinical Research Institute, Duke University, Durham, North Carolina and colleagues in the work group, who were charged with the task of figuring out how best to implement newborn screening for CCHD. They met for 2 days in January 2011.
Consistent with prior statements and conclusions, the work group concluded that a “significant body of evidence” suggests that early detection of CCHD through pulse oximetry monitoring is an effective strategy for reducing morbidity and mortality in young children.
Recognizing “the challenges of implementing a new screening program,” the work group now offers the following specific recommendations to help hospitals and birthing centers implement pulse oximetry monitoring for CCHD:
- Use motion-tolerant pulse oximeters that report functional oxygen saturation cleared by the FDA for use in newborns.
- Use the recommended screening algorithm and qualified personnel (e.g., nurses, allied health technicians) educated in the use of the algorithm and trained in pulse oximetry monitoring of newborns.
- Be aware that the algorithm cut-offs may need to be adjusted in high-altitude nurseries.
- In the presence of an abnormal pattern of low blood oxygen saturation, do a complete clinical evaluation by a licensed, independent practitioner. In the absence of other findings to explain hypoxemia, CCHD needs to be excluded, based on a comprehensive echocardiogram interpreted by a pediatric cardiologist before discharge to home. If an echocardiogram cannot be performed in the hospital or birthing center and diagnosis by telemedicine is not possible, strong consideration should be made for transfer to another medical center for diagnosis. Before implementing screening, protocols for arranging diagnostic follow-up should be established.
- Establish alliances between hospitals/birthing centers and local and state public health agencies to develop strategies for quality assurance and to monitor the impact of screening.
The work group also recommends that primary care providers make sure that newborns in their practice are appropriately screened and help facilitate long-term follow-up of those diagnosed with CCHD. The group calls for developing standards for electronic reporting of pulse oximetry monitoring and diagnostic outcomes.
“To assure that screening is implemented in a safe and effective manner, the work group strongly endorsed the development and funding of a national technical assistance center to disseminate best practices; to partner with public health agencies to monitor the impact of screening; to evaluate and make recommendations regarding workforce and related infrastructure needs; and, to coordinate research to help answer the important unanswered questions regarding screening thresholds and optimal strategies for diagnosis and follow-up.”
The Secretary of HHS has directed an interagency work group to “develop a plan to address these critical gaps prior to recommending that CCHD be a part of the recommended uniform screening panel,” the work group notes.