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Simple air therapy may protect NICU newborns from painful diaper rash

NCT ID NCT06958003

Prevention Sponsor: TriHealth Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving NICU babies 3-5 minutes of air time during diaper changes can prevent and treat diaper dermatitis (rash). Researchers will enroll 320 infants born at 30 weeks or older. The goal is to see if this simple, no-cost intervention reduces the occurrence of diaper rash in the NICU.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
air therapy (exposure to air)
What this could lead to
If it works, this simple, drug-free method could reduce painful diaper rash in fragile NICU babies.
What could go wrong
This is a small, early-stage study without a control group, so results may not be conclusive. The benefit of air exposure may be minimal compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

30 weeks to 1 year

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Receiving care at Good Samaritan Hospital NICU * At least 30 weeks gestation at birth and corrected or older or corrected gestation * Birth to 1 year old * Stable vital signs (temperature, pulse, blood pressure, and oxygen saturation) Exclusion Criteria: * Parent/legal guardian unable or unavailable to consent to involvement in the study * Congenital malformation impacting diaper area or spine

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Conditions

The condition(s) this trial relates to.

Diaper Rash

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diaper dermatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220, United States

More trials for these conditions

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