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

320 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

Is air therapy for diaper rash safe for humans?

There is no specific safety data on air therapy for diaper rash, but modern disposable diapers have been thoroughly evaluated for safety and skin compatibility, suggesting that products designed for the diaper area are generally safe. ^{1 2 3 4 5}

How does the treatment Airtime for diaper rash differ from other treatments?

Airtime is unique because it involves air therapy, which is a non-invasive approach that allows the skin to breathe and heal naturally, unlike creams or ointments that are typically used for diaper rash. ^{6 7 8 9 10}

What is the purpose of this trial?

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).

Research Team

Gina Marie Allaire

Principal Investigator

TriHealth Inc.

Eligibility Criteria

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

I am under 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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety evaluation for ingredients used in baby care products: Consideration of diaper rash. [2018]

2. Spain pubmed.ncbi.nlm.nih.gov

[Clinical presentation and treatment of diaper dermatitis--part II]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Impact of 2 Disposable Diapers in the "Natural" Diaper Category on Diapered Skin Condition. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Setting the Record Straight on Diaper Rash and Disposable Diapers. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis to Pampers Drymax. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Surfactant use for neonatal lung injury: beyond respiratory distress syndrome. [2019]

8. Norway pubmed.ncbi.nlm.nih.gov

Synthetic or natural surfactants. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled trial of human surfactant given at birth versus rescue administration in very low birth weight infants with lung immaturity. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Natural surfactant for neonatal respiratory distress syndrome in very premature infants: a 1992 update. [2019]