Preterm Newborns, Skin IntegrityPRO-NEO-SKINNCT07753863
Use of a Silicone Sensor to Protect Fragile Neonatal Skin in Moderately Preterm Infants Needing Continuous Monitoring
A study testing Nellcor™ OxySoft™ and MasimoRD SET NeoPt-500 in people with Preterm Newborns, Skin Integrity, run by Paolo Manzoni Study Group at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Preterm Newborns, Skin Integrity
- What is being tested?
- Nellcor™ OxySoft™ and MasimoRD SET NeoPt-500
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Parental refusal
- Death prior to the first investigational assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Nellcor™ OxySoft™, MasimoRD SET NeoPt-500
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MasimoRD SET NeoPt-500Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | use of the investigational sensor Receives: Device: Nellcor™ OxySoft™ |
| Arm B | Active comparator | use of a SOC , comparator sensor Receives: Device: MasimoRD SET NeoPt-500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin integrity
measurement of Transepidermal water loss (TEWL), this last being a key indicator of the skin barrier function,
Measured: 14 days
skin integrity
Count of skin cells that can be retrieved adhered in the removed sensors after one week of use
Measured: 14 days
skin integrity
clinical dermatological score of skin integrity
Measured: 14 days
Secondary outcomes (6)
1. Late-onset sepsis
Measured: 14 days
2. CLABSI
Measured: 14 days
3. skin infection
CLINICAL ASSESSMENT
Measured: 14 days
4. adverse effects/intolerances to treatment
Measured: 14 days
5. weight difference from admission to discharge
Measured: 14 days
6. length of hospital stay (LOS)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Newborns, Skin IntegrityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paolo Manzoni Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Manzoni Study Group, Paolo Manzoni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753863
- Sponsor's protocol ID
- 3
- Acronym
- PRO-NEO-SKIN
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07753863
- Acronym / sponsor ID
- PRO-NEO-SKIN / 3
- Conditions
- Preterm Newborns, Skin Integrity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Paolo Manzoni Study GroupUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Device: Nellcor™ OxySoft™use of the investigational sensor |
| Arm B | Active comparator | Device: MasimoRD SET NeoPt-500use of a SOC , comparator sensor |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Parental refusal
- Death prior to the first investigational assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Arm A |
| MasimoRD SET NeoPt-500The 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. | Device | Arm B |
Primary outcome
skin integrity
Time frame: 14 days
measurement of Transepidermal water loss (TEWL), this last being a key indicator of the skin barrier function,
skin integrity
Time frame: 14 days
Count of skin cells that can be retrieved adhered in the removed sensors after one week of use
skin integrity
Time frame: 14 days
clinical dermatological score of skin integrity
6 secondary outcomes
1. Late-onset sepsis
Time frame: 14 days
2. CLABSI
Time frame: 14 days
3. skin infection
Time frame: 14 days
4. adverse effects/intolerances to treatment
Time frame: 14 days
5. weight difference from admission to discharge
Time frame: 14 days
6. length of hospital stay (LOS)
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nellcor™ OxySoft™ and MasimoRD SET NeoPt-500 in people with Preterm Newborns, Skin Integrity, run by Paolo Manzoni Study Group at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin integrity (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.