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

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.

Study Overview

• Status: Completed
• Conditions: Critical Congenital Heart Disease
• Intervention / Treatment: Diagnostic test: Pulse oximetry

• Study Type: Interventional
• Enrollment (Actual): 44140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Agen, France, 47000
    • CH Agen
  • Agen, France, 47000
    • Clinique Esquirol - Saint Hilaire
  • Angouleme, France, 16959
    • CH Angoulême
  • Blaye, France, 33394
    • CH de la Haute Gironde
  • Bordeaux, France, 33077
    • Polyclinique Bordeaux Nord Aquitaine
  • Brive-la-Gaillarde, France, 19100
    • CH BRIVE
  • Bruges, France, 33523
    • Clinique Jean Villar
  • Chatellerault, France, 86106
    • CH Châtellerault
  • Dax, France, 40100
    • CH Dax
  • Guéret, France, 23000
    • CH Guéret
  • La Teste de buch, France, 33260
    • CH d'Arcachon
  • La rochelle, France, 17019
    • Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis
  • Libourne, France, 33505
    • CH Robert Boulin
  • Limoges, France, 87000
    • CHU Limoges
  • Limoges, France, 87000
    • Clinique Emailleurs
  • Lormont, France, 33310
    • Polyclinique Rive droite
  • Marmande, France, 47207
    • Ch Marmande
  • Mont de Marsan, France, 40024
    • CH Mont de Marsan
  • Niort, France, 79000
    • CH Niort
  • Perigueux, France, 24000
    • Ch Perigueux
  • Pessac, France, 33604
    • CHU de Bordeaux
  • Poitiers, France, 86000
    • CHU de Poitiers
  • Rochefort, France, 17301
    • CH Rochefort
  • Saint Junien, France, 87200
    • CH Saint Junien
  • Saintes, France, 17100
    • CH Saintes
  • Soyaux, France, 16800
    • Clinique Soyaux
  • Talence, France, 33401
    • Maison de Santé Protestante de Bordeaux Bagatelle
  • Tulle, France, 19012
    • CH de Tulle
  • Villeneuve-sur-Lot, France, 47305
    • CH Villeneuve-sur-Lot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 day (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Before period group; Strictly observational in order to assess the current screening strategy as it is conducted in real life
Experimental: After period group; Consist in a systematic pulse oximetry screening where all eligible newborns will be included in the same maternity wards	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Antoine Bénard, MD, University Hospital, Bordeaux; Principal Investigator: Julie THOMAS, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Pulse oximetry; Asymptomatic newborns
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: CHUBX 2015/27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No