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Enrolling by invitationNCT06958003Updated Oct 13, 2026

Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime

An interventional study of Air Therapy in Diaper Dermatitis, sponsored by TriHealth Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 30 Weeks to 1 Year. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by TriHealth Inc. · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2025, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
30 Weeks to 1 Year
Sex
All
01

Study 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).

02

Conditions studied

  • Diaper Dermatitis

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03

In context

Diaper Rash

38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.

This study's planned enrollment of 320 is above the median of 92 across 28 interventional studies indexed under Diaper Rash.

Browse Diaper Rash studies →

Lead sponsor

TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Weeks to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Parent/legal guardian unable or unavailable to consent to involvement in the study
  • Congenital malformation impacting diaper area or spine
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    Air Therapy

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

    Other: Air Therapy

  • No intervention
    Routine Care

    Patients will receive routine diaper care

Interventions

  • OtherAir Therapy

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

06

What researchers measure

Primary outcomes

  1. Occurrence of diaper dermatitis

    Whether infant is diagnosed with diaper dermatitis while in the NICU

    Time frame: from admission to discharge from NICU, up to 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06958003
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
May 6, 2025
Start date
Jan 21, 2025
Primary completion
Jul 21, 2027 (estimated)
Completion
Dec 21, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Gina Marie Allaire
principal investigator · TriHealth Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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