MEcánica respiratoria para la administración de surfactante exógeno individualizado (REMEDIES)
Un ensayo controlado aleatorizado de mecánica oscilatoria versus criterios basados en oxigenación para la terapia con surfactante
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will allow a 5-day reduction in the duration of respiratory support as compared to standard practice in preterm infants between 27+0 and 32+6 weeks' gestation. The secondary objectives are:
- to determine if a lung mechanics-based approach for administering surfactant will change treatment timing; and
- to assess the impact of the novel approach on other neonatal general outcomes. The study will take place within the neonatal intensive care units. Non-invasive respiratory support will be delivered by nasal CPAP with a starting pressure of 5-8 cmH2O. FiO2 will be titrated in order to achieve the target SpO2 91-95%.
Infants matching the clinical criteria for inclusion will be randomized in two arms following the current data protection and confidentiality regulations. Central, computer-generated randomization (allocation 1:1) with variable block sizes according to gestational age will be used. Infants will be stratified according to gestational age (27+0 -28+6 weeks; 29+0 -30+6 weeks; 31+0 -32+6 weeks) and center.
Study Arms:
A) Surfactant administration following oxygenation-based criteria (clinical assessment) (control) B) Surfactant administration following both lung mechanics assessment OR oxygenation-based criteria (clinical assessment) (intervention).
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Anna Lavizzari, MD
- Número de teléfono: 0039 3208715095
- Correo electrónico: anna.lavizzari@gmail.com
Ubicaciones de estudio
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Milan, Italia
- Reclutamiento
- Fondazione IRCCs Cà Granda Ospedale Maggiore Policlinico
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Contacto:
- Anna Lavizzari, MD
- Número de teléfono: 0039 3208715095
- Correo electrónico: anna.lavizzari@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Gestational age (GA) ≥ 27+0 and < 33+0 weeks
- Spontaneously breathing infants, requiring non-invasive respiratory support (nasal CPAP or bilevel nasal CPAP). Criteria for commencement of non-invasive respiratory support: FiO2 >0.30 for target SpO2 88-93% or Silverman score ≥ 5.
- Inborn
- Written parental consent obtained
- Administration of Caffeine bolus 20 mg/kg IV or PO as per standard care
Exclusion Criteria:
- Major congenital anomalies
- Need of intubation in delivery suite according to the AAP guidelines for neonatal resuscitation or early at the admission in NICU (within one hour from birth).
- Surfactant therapy prior to the study entry
- Severe birth asphyxia, defined by APGAR score ≤ 5 at 10 minutes after birth OR continued need for resuscitation 10 minutes after birth OR pH < 7.0 or base excess (BE) < -12 mmol/l on umbilical cord or on an arterial or capillary blood sample obtained within 1 hour from birth OR moderate to severe encephalopathy
- Respiratory failure secondary to conditions other that RDS as identified by lung imaging (air leaks, lung malformations…)
- Any clinical condition which may place the infants at undue risk as deemed by clinicians
- Participation to trials with competitive outcomes or likely to have an impact on the primary outcome of the study
- Outborn patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: A/Control
Surfactant administration following clinical assessment |
Surfactant is administered following oxygenation-based criteria |
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Experimental: B/Intervention
Surfactant administration following both lung mechanics assessment and clinical assessment |
Surfactant is administered following oxygenation-based criteria and if the Xrs is ≤ -23.3 cmH2O*s /L |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Days of respiratory support
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of days of required respiratory support |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
First surfactant administration
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Time of first surfactant administration (in hours) |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Days of non-invasive respiratory support
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of days of non-invasive respiratory support |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
|
Days of invasive respiratory support
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Number of days of invasive respiratory support |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
|
Patients intubated and mechanically ventilated
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of patients intubated and mechanically ventilated |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
|
Patients receiving multiple surfactant doses
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of patients receiving multiple surfactant doses |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Days on supplemental oxygen
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of days on supplemental oxygen |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Total cumulative oxygen exposure
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Total cumulative oxygen exposure computed as the time integral of the FiO2 values |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
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Infants receiving more than 28 days of respiratory support
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Number of infants receiving more than 28 days of respiratory support |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
|
Infants developing BPD
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of infants developing BPD according to the definition by NICHD 2016 |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Infants developing air-leaks
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of infants developing air-leaks |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
|
Infants developing prematurity-associated complications
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Number of infants developing prematurity-associated complications (severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), sepsis, retinopathy of prematurity (ROP), patent ductus arteriosus requiring pharmacological or surgical treatment) |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
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Infants discharged home with oxygen or respiratory support
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of infants discharged home with oxygen or respiratory support |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
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Days to achieve full-enteral feeding
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
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Number of days to achieve full-enteral feeding (160 ml/kg/day of milk intake) |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
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Days of hospitalization
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Number of days of hospitalization |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
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Infants receiving postnatal steroids
Periodo de tiempo: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Number of infants receiving postnatal steroids |
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 48 months"
|
Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Sperimentazione 3115
- Studio Numero 6379 (Otro identificador: Comitato Etico Milano Area 2)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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