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

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ClinicalTrials.gov Identifier: NCT03078218
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Critical Congenital Heart Disease Diagnostic Test: Pulse oximetry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34704 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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.




Primary Outcome Measures :
  1. Incremental cost-effectiveness ratio [ Time Frame: Up to 12 month of each period ]
    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.


Secondary Outcome Measures :
  1. Incremental cost per life saved [ Time Frame: Up to 12 month of each period ]
    Difference of mean costs between the two strategies divided by the difference in the number of saved lives between the two strategies.

  2. Net monetary benefit for the French Health System of generalizing the pulse oximetry screening [ Time Frame: Up to 12 month of each period ]
  3. Cost of pulse oximetry screening for critical congenital heart defects in France. [ Time Frame: The duration of a pulse oximetry examination ]
    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

  4. Performances of pulse oximetry for the diagnostic of CCHD and non-cardiac disease [ Time Frame: Up to 12 month of the after period ]
    sensibility, specificity, positive predictive value, negative predictive value



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078218


Contacts
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Contact: Julie THOMAS, MD (0)5.57.65.61.10 ext +33 julie.thomas@chu-bordeaux.fr
Contact: Nathalie TERRAS nathalie.terras@chu-bordeaux.fr

Locations
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France
CH Agen Recruiting
Agen, France, 47000
Contact: Claire BRIENNON, MD         
Principal Investigator: Claire BRIENNON, MD         
Clinique Esquirol - Saint Hilaire Recruiting
Agen, France, 47000
Contact: Jacques ELHARRAR, MD         
Principal Investigator: Jacques ELHARRAR, MD         
CH Angoulême Recruiting
Angouleme, France, 16959
Contact: Mélie SARREAU, MD         
Principal Investigator: Mélie SARREAU, MD         
CH de la Haute Gironde Recruiting
Blaye, France, 33394
Contact: Alexsie TENDA, MD         
Principal Investigator: Alexsie TENDA, MD         
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33077
Contact: Leïla PLANTARD-CHEKROUN, MD         
Principal Investigator: Leïla PLANTARD-CHEKROUN, MD         
CH Brive Recruiting
Brive-la-Gaillarde, France, 19100
Contact: Stéphane HARANT, MD         
Principal Investigator: Stéphane HARANT, MD         
Clinique Jean Villar Recruiting
Bruges, France, 33523
Contact: Sybille PELRAS, MD         
Principal Investigator: Sybille PELRAS, MD         
CH Châtellerault Recruiting
Chatellerault, France, 86106
Contact: Florence COMPAIN, MD         
Principal Investigator: Florence COMPAIN, MD         
CH Dax Recruiting
Dax, France, 40100
Contact: Eric ROUSSEAU, MD         
Principal Investigator: Eric ROUSSEAU, MD         
CH Guéret Recruiting
Guéret, France, 23000
Contact: Céline HIVERT, MD         
Principal Investigator: Céline HIVERT, MD         
Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis Recruiting
La rochelle, France, 17019
Contact: Viviane BAUER, MD         
Principal Investigator: Viviane BAUER, MD         
Sub-Investigator: Marie HALBWACHS ROTH, MD         
CH d'Arcachon Recruiting
La Teste de buch, France, 33260
Contact: Marcelin KIBELO, MD         
Principal Investigator: Marcelin KIBELO, MD         
CH Robert Boulin Terminated
Libourne, France, 33505
CHU Limoges Recruiting
Limoges, France, 87000
Contact: Laure PONTHIER, MD         
Principal Investigator: Laure PONTHIER, MD         
Clinique Emailleurs Recruiting
Limoges, France, 87000
Contact: Eric SELLAM, MD         
Principal Investigator: Eric SELLAM, MD         
Polyclinique Rive droite Recruiting
Lormont, France, 33310
Contact: Béatrice BAUDOIN, MD         
Principal Investigator: Béatrice BAUDOIN, MD         
CH Marmande Recruiting
Marmande, France, 47207
Contact: Jean-Roger SASSIN, MD         
Principal Investigator: Jean-Roger SASSIN, MD         
CH Mont de Marsan Recruiting
Mont de Marsan, France, 40024
Contact: Laurence PRIQUELER, MD         
Principal Investigator: Laurence PRIQUELER, MD         
CH Niort Recruiting
Niort, France, 79000
Contact: Odile CAMARD, MD         
Principal Investigator: ODILE CAMARD, MD         
CH Périgueux Recruiting
Perigueux, France, 24000
Contact: Loïc FRITSCH, MD         
Principal Investigator: Loïc FRITSCH, MD         
CHU de Bordeaux Recruiting
Pessac, France, 33604
Contact: Julie THOMAS, MD       julie.thomas@chu-bordeaux.fr   
Contact: Nathalie TERRAS       nathalie.terras@chu-bordeaux.fr   
Sub-Investigator: Eric DUMAS-DE-LA-ROQUE, MD         
Principal Investigator: Julie THOMAS, MD         
CHU de Poitiers Recruiting
Poitiers, France, 86000
Contact: Fabrice PIERRE, MD         
Principal Investigator: Fabrice PIERRE, MD         
CH Rochefort Recruiting
Rochefort, France, 17301
Contact: Anne LISKA, MD         
Principal Investigator: Anne LISKA, MD         
CH Saint Junien Recruiting
Saint Junien, France, 87200
Contact: Nasser BOUHAJJA, MD         
Principal Investigator: Nasser BOUHAJJA, MD         
CH Saintes Recruiting
Saintes, France, 17100
Contact: Sandra ROBERT, MD         
Principal Investigator: Sandra ROBERT, MD         
Clinique Soyaux Recruiting
Soyaux, France, 16800
Contact: Bénédicte TESSIER, MD         
Principal Investigator: Bénédicte TESSIER, MD         
Maison de Santé Protestante de Bordeaux Bagatelle Recruiting
Talence, France, 33401
Contact: Emilie ROQUAND-WAGNER, MD         
Principal Investigator: Emilie ROQUAND-WAGNER, MD         
CH de Tulle Recruiting
Tulle, France, 19012
Contact: Frédéric VAZEILLE, MD         
Principal Investigator: Frédéric VAZEILLE, MD         
CH Villeneuve-sur-Lot Recruiting
Villeneuve-sur-Lot, France, 47305
Contact: Nathalie TERRASSE, MD         
Principal Investigator: Nathalie TERRASSE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Julie THOMAS, MD University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03078218     History of Changes
Other Study ID Numbers: CHUBX 2015/27
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Pulse oximetry
Asymptomatic newborns

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities