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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Biella
-
Ponderano, Biella, Italia, 13875
- ASL BI Ospedale degli Infermi
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Aktiv komparator: Arm B
use of a SOC , comparator sensor
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
skin integrity
Tidsramme: 14 days
|
measurement of Transepidermal water loss (TEWL), this last being a key indicator of the skin barrier function,
|
14 days
|
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skin integrity
Tidsramme: 14 days
|
Count of skin cells that can be retrieved adhered in the removed sensors after one week of use
|
14 days
|
|
skin integrity
Tidsramme: 14 days
|
clinical dermatological score of skin integrity
|
14 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1. Late-onset sepsis
Tidsramme: 14 days
|
14 days
|
|
|
2. CLABSI
Tidsramme: 14 days
|
14 days
|
|
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3. skin infection
Tidsramme: 14 days
|
CLINICAL ASSESSMENT
|
14 days
|
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4. adverse effects/intolerances to treatment
Tidsramme: 14 days
|
14 days
|
|
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5. weight difference from admission to discharge
Tidsramme: 14 days
|
14 days
|
|
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6. length of hospital stay (LOS)
Tidsramme: 14 days
|
14 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 3
Plan for individuelle deltakerdata (IPD)
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