Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns

Critical Congenital Heart Disease Clinical Trial

— OXYNAT  

Official title:

Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078218
• Other study ID #: CHUBX 2015/27
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: January 7, 2020

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44140
• Est. completion date: January 7, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

Inclusion Criteria:

BEFORE Period: newborns

• aged at birth superior or equal to 35 weeks of gestation (= 35+ 0 days weeks of gestation)

• borned in metropolitan France in involved maternity wards.

• Asymptomatic before the screening (no respiratory signs, neither collapse or cardiac arrest).

AFTER Period: newborns

• aged at birth superior or equal to 35 weeks of gestation (= 35+ 0 days weeks of gestation)

• borned in metropolitan France in involved maternity wards.

• Asymptomatic before the screening (no respiratory signs, neither collapse or cardiac arrest).

• With consent done by the 2 parents.

• Parents covered with the French National health insurance

Exclusion Criteria:

• Newborns with a prenatally diagnosed congenital cyanotic malformation or any other cyanotic affection.

• Newborns with a postnatal pre-screening diagnosed congenital cyanotic malformation or any other cyanotic affection.

Related Conditions & MeSH terms

• Critical Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Diagnostic Test:
• Pulse oximetry
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.

Locations

Country	Name	City	State
France	CH Agen	Agen
France	Clinique Esquirol - Saint Hilaire	Agen
France	CH Angoulême	Angouleme
France	CH de la Haute Gironde	Blaye
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	CH Brive	Brive-la-Gaillarde
France	Clinique Jean Villar	Bruges
France	CH Châtellerault	Chatellerault
France	CH Dax	Dax
France	CH Guéret	Guéret
France	Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis	La rochelle
France	CH d'Arcachon	La Teste de buch
France	CH Robert Boulin	Libourne
France	CHU Limoges	Limoges
France	Clinique Emailleurs	Limoges
France	Polyclinique Rive droite	Lormont
France	CH Marmande	Marmande
France	CH Mont de Marsan	Mont de Marsan
France	CH Niort	Niort
France	CH Périgueux	Perigueux
France	CHU de Bordeaux	Pessac
France	CHU de Poitiers	Poitiers
France	CH Rochefort	Rochefort
France	CH Saint Junien	Saint Junien
France	CH Saintes	Saintes
France	Clinique Soyaux	Soyaux
France	Maison de Santé Protestante de Bordeaux Bagatelle	Talence
France	CH de Tulle	Tulle
France	CH Villeneuve-sur-Lot	Villeneuve-sur-Lot

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental cost-effectiveness ratio	Difference of mean costs between the two strategies divided by the difference in the number of complications between the two strategies. Complications of interest are: acute respiratory distress, acute cardio-circulatory distress (collapse, acidosis, shock, multivisceral failure), and death.	Up to 12 month of each period
Secondary	Incremental cost per life saved	Difference of mean costs between the two strategies divided by the difference in the number of saved lives between the two strategies.	Up to 12 month of each period
Secondary	Net monetary benefit for the French Health System of generalizing the pulse oximetry screening		Up to 12 month of each period
Secondary	Cost of pulse oximetry screening for critical congenital heart defects in France.	Costs will be calculated in the perspective of the French Health System. The test will be realised before 24 hours of life in a newborn aged at least of 35 weeks of gestation	The duration of a pulse oximetry examination
Secondary	Performances of pulse oximetry for the diagnostic of CCHD and non-cardiac disease	sensibility, specificity, positive predictive value, negative predictive value	Up to 12 month of the after period