Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns
Palabras clave
Abstracto
fechas
Verificado por última vez: | 08/31/2018 |
Primero enviado: | 02/05/2017 |
Inscripción estimada enviada: | 03/06/2017 |
Publicado por primera vez: | 03/12/2017 |
Última actualización enviada: | 09/27/2018 |
Última actualización publicada: | 09/30/2018 |
Fecha de inicio real del estudio: | 02/28/2017 |
Fecha estimada de finalización primaria: | 02/29/2020 |
Fecha estimada de finalización del estudio: | 02/29/2020 |
Condición o enfermedad
Intervención / tratamiento
Diagnostic Test: After period group
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
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: After period group 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. |
Criterio de elegibilidad
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | 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. |
Salir
Medidas de resultado primarias
1. Incremental cost-effectiveness ratio [Up to 12 month of each period]
Medidas de resultado secundarias
1. Incremental cost per life saved [Up to 12 month of each period]
2. Net monetary benefit for the French Health System of generalizing the pulse oximetry screening [Up to 12 month of each period]
3. Cost of pulse oximetry screening for critical congenital heart defects in France. [The duration of a pulse oximetry examination]
4. Performances of pulse oximetry for the diagnostic of CCHD and non-cardiac disease [Up to 12 month of the after period]