Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns
Condition: Critical Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Persistant hypoxemia in the newborn confers, even isolated, an abnormal clinical situation,
      that needs to be addressed for an adequate diagnosis and an optimal treatment.

      If during the first hours of life, hypoxemia is frequent and often transient, beyond that, it
      is necessary to search the various etiological conditions such as a critical congenital heart
      disease (CCHD) or a non cardiac affection (sepsis, anemia, respiratory disease).

      Newborn pulse oximetry screening identifies babies with critical congenital heart disease
      (CCHD) based on the rational that they frequently have a degree of hypoxemia that may be
      clinically undetectable. CCHDs are life-threatening forms of congenital heart disease (CHD)
      occuring in 2-3/1000 live births but accounting for 3%-7.5% of infant deaths.

      Early detection is beneficial because of acute collapse, if not resulting in death, is
      associated with a worse surgical and neurodevelopmental outcome.

      Currently, screening for CCHD involves antenatal ultrasound scanning and post-natal physical
      examination. Although antenatal detection rates have improved over recent years and can be as
      high as 70%-80% in some centers, this is not consistent. Indeed, in "Nouvelle Aquitaine"
      overall <50% of CCHDs are detected before birth. In addition, up to a third of infants with
      CCHD may be missed on post-natal examination. Pulse oximetry screening can help to close the
      "diagnostic gap' that is, increase the detection of babies who slip through the current
      screening net.

      Several large European studies and a subsequent meta-analysis have shown that pulse oximetry
      screening is a highly specific (99.9%) and moderately sensitive (76.5%) test which increases
      CCHD detection rates. The high specificity results in a low false-positive rate 0.05% to
      0.5%. But those babies with a Positive Test, if they may not have CCHD, they may be diagnosed
      with other causes of hypoxemia (congenital pneumonia, sepsis, persistent pulmonary
      hypertension,...). As with CCHD, delayed recognition of these conditions can result in
      postnatal collapse and significant morbidity and mortality. It is also more useful to
      consider these conditions as secondary targets of screening and to remember they constitute
      30%-70% of false positives. In 2011, the US Health and Human Services Secretary recommended
      that pulse oximetry screening for CCHD be added to the Recommended Uniform Screening Panel.
      In Europe, implementation is advanced in such countries as North European Countries, and
      Switzerland. There isn't yet any European guidance. In France, the implementation is limited
      to local and transient experiments. The feasibility, usefulness and cost-effectiveness of
      routine pulse oximetry screening have not been evaluated so far. The French setting has two
      specificities : 1/ the antenatal detection rate is considered to be rather high. 2/ in
      contrast to a lot of other European countries, early discharge from the maternity ward before
      48 hours of life is not common, decreasing the risk of discharging a baby with undiagnosed
      CCHD, but not saving babies from collapse.

      - The Investigators hypothesis is that routine pulse oximetry screening in asymptomatic
      newborns would allow to reduce the incidence of complications related to CCHDs as well as
      those related to non cardiac pathologies for a reasonable cost for the French Health Care
      System.
    


Intervention name(s): Pulse oximetry
Intervention type(s): Diagnostic Test
Intervention description(s): The tool evaluated will be the assumption of peripherical arterial oxygen saturation by pulse oximetry. The pulse oximetry will identify hypoxemic CCHD and hypoxemic non-cardiac disease before discharge.The test will be realised before 24 hours of life in a newborn aged at least of 35 weeks of gestation.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Multicenter controlled before and after study conducted in Nouvelle Aquitaine, including types 1, 2 and 3 maternity wards.
The BEFORE period will be strictly observational in order to assess the current screening strategy as it is conducted in real life.
The AFTER period will be consist in a systematic pulse oximetry screening where all eligible newborns will be included in the same maternity wards as the BEFORE period.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pulse oximetry; Asymptomatic newborns