Air Therapy for Diaper Rash

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: TriHealth Inc.

Disqualifiers: Congenital malformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a short, 3-5 minute air therapy session, known as "Airtime," can prevent and treat diaper rash in infants. Babies in the NICU at Good Samaritan Hospital, who are at least 30 weeks gestation and have stable vital signs, may qualify. Participants will receive either this air therapy along with their regular diaper care or just the routine care. The goal is to assess whether airing out the skin can help prevent diaper rash. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance infant care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that air therapy is safe for infants in the NICU?

Research has shown that allowing the diaper area to get some air can help with diaper rash. While specific safety data on using air for diaper rash is lacking, similar treatments like oxygen therapy have proven effective. For instance, studies found that oxygen therapy significantly reduced diaper rash in just a few days. No major side effects have been reported from using air for diaper rash, suggesting that air therapy might be safe and easy to tolerate. However, consulting healthcare providers for personal advice remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard diaper rash treatments that typically involve creams or ointments, Air Therapy offers a unique approach by incorporating brief sessions of air exposure. This method enhances routine diaper care by allowing the skin to breathe, potentially reducing moisture and irritation more effectively. Researchers are excited about this treatment because it introduces a non-invasive, natural way to support skin healing, which could be especially beneficial for sensitive infant skin.

What evidence suggests that air therapy is effective for diaper rash?

Research has shown that oxygen therapy can greatly reduce diaper rash within 24 to 72 hours. Studies have found that airing out the diaper area helps treat skin inflammation. Oxygen effectively heals wounds. In this trial, participants in the Air Therapy arm will receive 3-5 minutes of air therapy alongside routine diaper care, which might help prevent and treat diaper rash by allowing the skin to breathe. Overall, evidence supports the idea that giving the skin time in the open air can help treat diaper rash. ^{1 2 3 4 6}

Who Is on the Research Team?

Gina Marie Allaire

Principal Investigator

TriHealth Inc.

Are You a Good Fit for This Trial?

This trial is for infants from birth to 1 year old who were at least 30 weeks gestation at birth, currently in the NICU of Good Samaritan Hospital with stable vital signs. Infants must not have congenital malformations affecting the diaper area or spine, and their parent or guardian must be able to consent.

Inclusion Criteria

Receiving care at Good Samaritan Hospital NICU

Stable vital signs (temperature, pulse, blood pressure, and oxygen saturation)

I am under 1 year old.

Exclusion Criteria

Parent/legal guardian unable or unavailable to consent to involvement in the study

Congenital malformation impacting diaper area or spine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 3-5 minutes of air therapy in addition to routine diaper care

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Airtime

Trial Overview The study is examining if using air therapy for 3-5 minutes can prevent and treat diaper dermatitis (diaper rash) in infants over 30 weeks gestation who are in the NICU.

How Is the Trial Designed?

Group I: Air Therapy Experimental Treatment 1 Intervention

Patients with receive 3-5 minutes of air therapy in addition to routine diaper care

Group II: Routine Care Active Control 1 Intervention

Patients will receive routine diaper care

Who Is Running the Clinical Trial?

TriHealth Inc.

Lead Sponsor

Trials

103

Recruited

54,100+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1355184124000097

The effect of oxygen on diaper dermatitis in infants Results. Oxygen therapy significantly reduced the severity of diaper dermatitis at the 24th, 48th, and 72 nd h (p < 0.05).

2. withpower.com withpower.com/trial/phase-diaper-dermatitis-2025-9d59a

Air Therapy for Diaper Rash · Info for Participants Trial Overview The study is examining if using air therapy for 3-5 minutes can prevent and treat diaper dermatitis (diaper rash) in infants over 30 weeks ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05427760?term=AREA%5BConditionSearch%5D(%22Diaper%20Rash%22)&rank=1

Effect of Using Oxygen on the Diaper Dermatitis in Infants Background: Airing the diaper area has a positive effect on dermatitis. In addition, it is reported in the literature that oxygen is effective in wound care ...

4. researchgate.net researchgate.net/publication/377649249_The_effect_of_oxygen_on_diaper_dermatitis_in_infants_A_randomized_controlled_trial

(PDF) The effect of oxygen on diaper dermatitis in infants In this randomized controlled trial, nasal high-flow therapy was compared with standard care (no nasal high-flow therapy or supplemental oxygen) in neonates ...

5. ijced.org ijced.org/archive/volume/7/issue/4/article/7781

Comparative evaluation of the clinical effects of high Air ... Conclusions: Both High Air-Through Soft Diaper and standard diaper in babies caused a significant increase in mean total diaper rash score. However, the extent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7027557/

Diaper dermatitis prevalence and severity These data suggest caregiver behaviors including prophylactic use of topical products, thorough cleaning after stooling and reduced time in an overnight diaper ...