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Use of a Silicone Sensor to Protect Fragile Neonatal Skin in Moderately Preterm Infants Needing Continuous Monitoring

NCT07753863 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-11

No results posted yet for this study

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

  • Preterm Newborns, Skin Integrity

Interventions

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.

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.

Sponsors & Collaborators

  • Paolo Manzoni Study Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753863 on ClinicalTrials.gov