Preterm Newborns, Skin Integrity
Conditions
Brief summary
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.
Interventions
DEVICENellcor™ OxySoft™
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.
DEVICEMasimoRD SET NeoPt-500
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.
Sponsors
Paolo Manzoni Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| skin integrity | 14 days | measurement of Transepidermal water loss (TEWL), this last being a key indicator of the skin barrier function, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. Late-onset sepsis | 14 days | — |
| 2. CLABSI | 14 days | — |
| 3. skin infection | 14 days | CLINICAL ASSESSMENT |
| 4. adverse effects/intolerances to treatment | 14 days | — |
| 5. weight difference from admission to discharge | 14 days | — |
| 6. length of hospital stay (LOS) | 14 days | — |
Countries
Italy
Outcome results
None listed