Use of a Silicone Sensor to Protect Fragile Neonatal Skin in Moderately Preterm Infants Needing Continuous Monitoring (PRO-NEO-SKIN)
Use of a Silicone Sensor to Protect Fragile Neonatal Skin in Moderately Preterm Infants Needing Continuous Monitoring: the PRO-NEO-SKIN (Protect Neonatal Skin) Pilot Study
Neonates, especially when born prematurely, have an inherently fragile skin, due to the overall prematurity and to the immature composition of epidermidis and skin dermal structures. In these patients, skin lesions are a frequent entry site for pathogens that may disseminate into the bloodstream causing systemic infection and sepsis.
Preterm neonates admitted in a Nursery feature medical conditions that require continuous monitoring of vital signs and parameters, namely heart rate, oxygen saturation, and systemic blood pressure. As a result, skin sensors used for monitoring are needed to remain in place on a 24/7 basis for very long periods - up to 3-4 months in the most extremely premature ones. Use of non-silicone adhesive sensors is associated to skin/dermal injuries, damage, loss of substance, bleeding and/or peeling in a way that is linearly related with the time of maintainance of the sensor.
As above mentioned, skin damage associated with disruptions of the skin barrier are a risk factor for a number of negative, clinically measurable outcomes of prematurity (such as skin infection, epidermal transpiration and subsequent systemic dehydration, scars, etc.) . In addition, skin colonization and subsequent systemic translocation by pathogens occurs more frequently under skin damage conditions. Hence, bloodstream infections originating from the skin reservoir, as well as central line- associated bloodstream infections (CLABSI), are features that are known to be negative outcomes of all conditions leading to skin damage and epidermal skin barrier impairment.
Recently, a first-in-class pulse oximetry sensor using a silicone adhesive to protect fragile skin and improve repositionability has become commercially available (Nellcor™ OxySoft™ SpO2 sensor). This innovation might obviously confer health benefits to an inherently fragile population like preterm infants. However, no study so far explored this area in this specific population of fragile patients.
The aim of this proposal is therefore to study whether preterm neonates may have clinically-measurable benefits from using this innovative device, compared with infants who use the comparator device that is currently used per standard of care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Biella
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Ponderano, Biella, Italia, 13875
- ASL BI Ospedale degli Infermi
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Preterm Infants 32+0 - 37+0 wGA (male and female)
- Need for hospitalization after birth (any cause)
- Absence of conditions related to congenital anomalies involving - or expected to involve- the skin
- Haematocrit at enrolment with values in the range 40-60 mg/dl
- Absence of immediate life-threatening conditions
- Written IC obtained from parents/legal guardian
Exclusion Criteria:
- Parental refusal
- Death prior to the first investigational assessment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Arm A
use of the investigational sensor
|
This sensors will positioned and maintained for 28 days, or till discharge, whichever first. Sensor will be changed every 7 days, and the removed sensors will undergo microscopy assessment to count the number of skin cells adhered on the sensor. |
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Comparador activo: Arm B
use of a SOC , comparator sensor
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The comparator sensor will positioned and maintained for 28 days, or till discharge, whichever first.
Sensor will be changed every 7 days, and the removed sensors will undergo microscopy assessment to count the number of skin cells adhered on the sensor.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
skin integrity
Periodo de tiempo: 14 days
|
measurement of Transepidermal water loss (TEWL), this last being a key indicator of the skin barrier function,
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14 days
|
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skin integrity
Periodo de tiempo: 14 days
|
Count of skin cells that can be retrieved adhered in the removed sensors after one week of use
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14 days
|
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skin integrity
Periodo de tiempo: 14 days
|
clinical dermatological score of skin integrity
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14 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
1. Late-onset sepsis
Periodo de tiempo: 14 days
|
14 days
|
|
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2. CLABSI
Periodo de tiempo: 14 days
|
14 days
|
|
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3. skin infection
Periodo de tiempo: 14 days
|
CLINICAL ASSESSMENT
|
14 days
|
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4. adverse effects/intolerances to treatment
Periodo de tiempo: 14 days
|
14 days
|
|
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5. weight difference from admission to discharge
Periodo de tiempo: 14 days
|
14 days
|
|
|
6. length of hospital stay (LOS)
Periodo de tiempo: 14 days
|
14 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- 3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
producto fabricado y exportado desde los EE. UU.
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