Use of a Silicone Sensor to Protect Fragile Neonatal Skin in Moderately Preterm Infants Needing Continuous Monitoring (PRO-NEO-SKIN)

August 7, 2026 updated by: Paolo Manzoni Study Group

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Biella
      • Ponderano, Biella, Italy, 13875
        • ASL BI Ospedale degli Infermi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
use of the investigational sensor
Device: Nellcor™ 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.
Active Comparator: Arm B
use of a SOC , comparator sensor
Device: MasimoRD 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin integrity
Time Frame: 14 days
measurement of Transepidermal water loss (TEWL), this last being a key indicator of the skin barrier function,
14 days
skin integrity
Time Frame: 14 days
Count of skin cells that can be retrieved adhered in the removed sensors after one week of use
14 days
skin integrity
Time Frame: 14 days
clinical dermatological score of skin integrity
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Late-onset sepsis
Time Frame: 14 days
14 days
2. CLABSI
Time Frame: 14 days
14 days
3. skin infection
Time Frame: 14 days
CLINICAL ASSESSMENT
14 days
4. adverse effects/intolerances to treatment
Time Frame: 14 days
14 days
5. weight difference from admission to discharge
Time Frame: 14 days
14 days
6. length of hospital stay (LOS)
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paolo Manzoni Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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