Clinical trial NCT03078218: Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns
Official title: Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Congenital Heart Disease
Keywords: Pulse oximetry
Asymptomatic newborns
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 44140
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incremental cost-effectiveness ratio
timeFrame: Up to 12 month of each period
Secondary outcomes:
measure: Incremental cost per life saved
timeFrame: Up to 12 month of each period
measure: Net monetary benefit for the French Health System of generalizing the pulse oximetry screening
timeFrame: Up to 12 month of each period
measure: Cost of pulse oximetry screening for critical congenital heart defects in France.
timeFrame: The duration of a pulse oximetry examination
measure: Performances of pulse oximetry for the diagnostic of CCHD and non-cardiac disease
timeFrame: Up to 12 month of the after period
Other outcomes:
Locations:
city: Agen
country: France
facility: CH Agen
city: Agen
country: France
facility: Clinique Esquirol - Saint Hilaire
city: Angouleme
country: France
facility: CH Angoulême
city: Blaye
country: France
facility: CH de la Haute Gironde
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Brive-la-Gaillarde
country: France
facility: CH Brive
city: Bruges
country: France
facility: Clinique Jean Villar
city: Chatellerault
country: France
facility: CH Châtellerault
city: Dax
country: France
facility: CH Dax
city: Guéret
country: France
facility: CH Guéret
city: La rochelle
country: France
facility: Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis
city: La Teste de buch
country: France
facility: CH d'Arcachon
city: Libourne
country: France
facility: CH Robert Boulin
city: Limoges
country: France
facility: CHU Limoges
city: Limoges
country: France
facility: Clinique Emailleurs
city: Lormont
country: France
facility: Polyclinique Rive droite
city: Marmande
country: France
facility: CH Marmande
city: Mont de Marsan
country: France
facility: CH Mont de Marsan
city: Niort
country: France
facility: CH Niort
city: Perigueux
country: France
facility: CH Périgueux
city: Pessac
country: France
facility: CHU de Bordeaux
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rochefort
country: France
facility: CH Rochefort
city: Saint Junien
country: France
facility: CH Saint Junien
city: Saintes
country: France
facility: CH Saintes
city: Soyaux
country: France
facility: Clinique Soyaux
city: Talence
country: France
facility: Maison de Santé Protestante de Bordeaux Bagatelle
city: Tulle
country: France
facility: CH de Tulle
city: Villeneuve-sur-Lot
country: France
facility: CH Villeneuve-sur-Lot
Study officials:
affiliation: University Hospital, Bordeaux
name: Julie THOMAS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
References: