Diaper DermatitisNCT06958003
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
A study testing Air Therapy in people with Diaper Dermatitis, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of this study is to investigate the use of 3-5 minutes air therapy for the prevention and treatment of diaper dermatitis in infants 30 weeks and older receiving care in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Ages 30 weeks to 1 year
- Conditions the study is for
- Diaper Dermatitis
- What is being tested?
- Air Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 21 Dec 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 30 weeks to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Parent/legal guardian unable or unavailable to consent to involvement in the study
- Congenital malformation impacting diaper area or spine
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
The purpose of this study is to investigate the use of 3-5 minutes air therapy for the prevention and treatment of diaper dermatitis in infants 30 weeks and older receiving care in the neonatal intensive care unit (NICU).
- Conditions
- Diaper Dermatitis
- Being tested
- Air Therapy
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air TherapyOther
3-5 minutes of air therapy in addition to routine diaper care
| Study group | Role | What they receive |
|---|---|---|
| Air Therapy | Experimental | Patients with receive 3-5 minutes of air therapy in addition to routine diaper care Receives: Other: Air Therapy |
| Routine Care | No intervention | Patients will receive routine diaper care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of diaper dermatitis
Whether infant is diagnosed with diaper dermatitis while in the NICU
Measured: from admission to discharge from NICU, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start21 Jan 2025
- Primary completion21 Jul 2027 (estimated)
- Study completion21 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper DermatitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gina Marie Allaire, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958003
- Sponsor's protocol ID
- 24-091
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
- ClinicalTrials.gov ID
- NCT06958003
- Acronym / sponsor ID
- 24-091
- Conditions
- Diaper Dermatitis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 21 Jul 2027 (estimated)
- Study completion
- 21 Dec 2027 (estimated)
- First posted
- 6 May 2025 (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.
The purpose of this study is to investigate the use of 3-5 minutes air therapy for the prevention and treatment of diaper dermatitis in infants 30 weeks and older receiving care in the neonatal intensive care unit (NICU).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air Therapy | Experimental | Other: Air TherapyPatients with receive 3-5 minutes of air therapy in addition to routine diaper care |
| Routine Care | No intervention | –Patients will receive routine diaper care |
Who may qualify
- Ages
- 30 weeks to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Parent/legal guardian unable or unavailable to consent to involvement in the study
- Congenital malformation impacting diaper area or spine
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 |
|---|---|---|
| Air Therapy3-5 minutes of air therapy in addition to routine diaper care | Other | Air Therapy |
Primary outcome
Occurrence of diaper dermatitis
Time frame: from admission to discharge from NICU, up to 6 months
Whether infant is diagnosed with diaper dermatitis while in the NICU
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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Not yet recruiting
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
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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.
Gina Marie Allaire principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Therapy in people with Diaper Dermatitis, run by TriHealth Inc. at 1 site in United States.
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 4 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: enrolling by invitation, as of the sponsor's last update on 13 Oct 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 United States. 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?
Occurrence of diaper dermatitis (time frame: from admission to discharge from NICU, up to 6 months). 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 13 Oct 2026.