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

NCT03078218 | Completed

• 1 other identifier: CHUBX 2015/27
• Study Type: interventional
• Target: 44,140
• Locations: 1 country
• Sites: 29

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

Keywords

Pulse oximetry; Asymptomatic newborns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incremental cost per life saved

  Up to 12 month of each period

• Net monetary benefit for the French Health System of generalizing the pulse oximetry screening

  Up to 12 month of each period

• Cost of pulse oximetry screening for critical congenital heart defects in France.

  The duration of a pulse oximetry examination

• Performances of pulse oximetry for the diagnostic of CCHD and non-cardiac disease

  Up to 12 month of the after period

Study Arms (2)

Before period group

NO INTERVENTION

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

After period group

EXPERIMENTAL

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

Diagnostic Test: Pulse oximetry

Interventions

Pulse oximetry 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.

After period group

Eligibility Criteria

• Age: 0 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (29)

CH Agen

Agen, 47000, France

Location

Clinique Esquirol - Saint Hilaire

Agen, 47000, France

Location

CH Angoulême

Angoulême, 16959, France

Location

CH de la Haute Gironde

Blaye, 33394, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

Location

CH Brive

Brive-la-Gaillarde, 19100, France

Location

Clinique Jean Villar

Bruges, 33523, France

Location

CH Châtellerault

Châtellerault, 86106, France

Location

CH Dax

Dax, 40100, France

Location

CH Guéret

Guéret, 23000, France

Location

Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis

La Rochelle, 17019, France

Location

CH d'Arcachon

La Teste-de-Buch, 33260, France

Location

CH Robert Boulin

Libourne, 33505, France

Location

CHU Limoges

Limoges, 87000, France

Location

Clinique Emailleurs

Limoges, 87000, France

Location

Polyclinique Rive droite

Lormont, 33310, France

Location

CH Marmande

Marmande, 47207, France

Location

CH Mont de Marsan

Mont-de-Marsan, 40024, France

Location

CH Niort

Niort, 79000, France

Location

CHU de Bordeaux

Pessac, 33604, France

Location

CH Périgueux

Périgueux, 24000, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CH Rochefort

Rochefort, 17301, France

Location

CH Saint Junien

Saint-Junien, 87200, France

Location

CH Saintes

Saintes, 17100, France

Location

Clinique Soyaux

Soyaux, 16800, France

Location

Maison de Santé Protestante de Bordeaux Bagatelle

Talence, 33401, France

Location

CH de Tulle

Tulle, 19012, France

Location

CH Villeneuve-sur-Lot

Villeneuve-sur-Lot, 47305, France

Location

MeSH Terms

Interventions

Oximetry

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Julie THOMAS, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: March 13, 2017
• Study Start: March 1, 2017
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (29)