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

February 12, 2026 updated by: TriHealth Inc.
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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Air Therapy
Patients with receive 3-5 minutes of air therapy in addition to routine diaper care
Other: Air Therapy
3-5 minutes of air therapy in addition to routine diaper care
No Intervention: Routine Care
Patients will receive routine diaper care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from admission to discharge from NICU, up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Investigators

  • Principal Investigator: Gina Marie Allaire, TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2025

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

December 21, 2027

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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