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

NCT ID: NCT03078218

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2020-01-07

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.

Conditions

Critical Congenital Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Before period group

Strictly observational in order to assess the current screening strategy as it is conducted in real life

Group Type: NO_INTERVENTION

No interventions assigned to this group

After period group

Consist in a systematic pulse oximetry screening where all eligible newborns will be included in the same maternity wards

Group Type: EXPERIMENTAL

Pulse oximetry

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 0 Hours
• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie THOMAS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Antoine BENARD, MD

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

CH Agen

Agen, , France

Clinique Esquirol - Saint Hilaire

Agen, , France

CH Angoulême

Angoulême, , 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

Châtellerault, , 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

CHU de Bordeaux

Pessac, , France

CH Périgueux

Périgueux, , 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, , France

Countries

France

Other Identifiers

CHUBX 2015/27

Identifier Type: -

Identifier Source: org_study_id