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

NCT07753863 | Not Yet Recruiting FDA Device

• 1 other identifier: 3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Effectiveness of the Investigational Sensor in Preserving Skin Integrity

Outcome Measures

Primary Outcomes (3)

• skin integrity

  measurement of Transepidermal water loss (TEWL), this last being a key indicator of the skin barrier function,

  14 days

• skin integrity

  Count of skin cells that can be retrieved adhered in the removed sensors after one week of use

  14 days

• skin integrity

  clinical dermatological score of skin integrity

  14 days

Secondary Outcomes (6)

• 1. Late-onset sepsis

  14 days

• 2. CLABSI

  14 days

• 3. skin infection

  14 days

• 4. adverse effects/intolerances to treatment

  14 days

• 5. weight difference from admission to discharge

  14 days

Study Arms (2)

Arm A

EXPERIMENTAL

use of the investigational sensor

Device: Nellcor™ OxySoft™

Arm B

ACTIVE COMPARATOR

use of a SOC , comparator sensor

Device: Nellcor™ OxySoft™

Interventions

Nellcor™ OxySoft™ DEVICE

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.

Arm A; Arm B

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Parental refusal
• Death prior to the first investigational assessment

Sponsors & Collaborators

• Paolo Manzoni Study Group: lead

Study Sites (1)

ASL BI Ospedale degli Infermi

Ponderano, Biella, 13875, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: August 10, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)