Can a silicone sensor shield preterm Babies' fragile skin?
NCT ID NCT07753863
First seen Aug 10, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This pilot study tests whether a new silicone-based pulse oximetry sensor can better protect the delicate skin of moderately preterm infants who need continuous vital sign monitoring. The sensor is designed to be gentler and more repositionable than standard adhesive sensors, potentially reducing skin damage and the risk of infections. Researchers will compare skin integrity, including water loss and cell adherence, between infants using this sensor and those receiving standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A silicone-based pulse oximetry sensor (Nellcor™ OxySoft™) designed to be gentler on fragile neonatal skin compared to standard adhesive sensors.
- What this could lead to
- If effective, this sensor could reduce skin damage and related infections in preterm infants, potentially improving outcomes and shortening hospital stays.
- What could go wrong
- This is a small pilot study, so results may not be conclusive. The sensor might not significantly improve skin integrity or reduce complications, and any device can cause irritation or adverse effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 days to 1 day
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ASL BI Ospedale degli Infermi
Ponderano, Biella, 13875, Italy