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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Biella
-
Ponderano, Biella, Italien, 13875
- ASL BI Ospedale degli Infermi
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
skin integrity
Tidsram: 14 days
|
measurement of Transepidermal water loss (TEWL), this last being a key indicator of the skin barrier function,
|
14 days
|
|
skin integrity
Tidsram: 14 days
|
Count of skin cells that can be retrieved adhered in the removed sensors after one week of use
|
14 days
|
|
skin integrity
Tidsram: 14 days
|
clinical dermatological score of skin integrity
|
14 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
1. Late-onset sepsis
Tidsram: 14 days
|
14 days
|
|
|
2. CLABSI
Tidsram: 14 days
|
14 days
|
|
|
3. skin infection
Tidsram: 14 days
|
CLINICAL ASSESSMENT
|
14 days
|
|
4. adverse effects/intolerances to treatment
Tidsram: 14 days
|
14 days
|
|
|
5. weight difference from admission to discharge
Tidsram: 14 days
|
14 days
|
|
|
6. length of hospital stay (LOS)
Tidsram: 14 days
|
14 days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 3
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .