NCT06958003

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Dec 2027

Study Start

First participant enrolled

January 21, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

April 21, 2025

Last Update Submit

February 12, 2026

Conditions

Diaper Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Occurrence of diaper dermatitis

    Whether infant is diagnosed with diaper dermatitis while in the NICU

    from admission to discharge from NICU, up to 6 months

Study Arms (2)

Air Therapy

EXPERIMENTAL

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

Other: Air Therapy

Routine Care

NO INTERVENTION

Patients will receive routine diaper care

Interventions

Air TherapyOTHER

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

Air Therapy

Eligibility Criteria

Age30 Weeks - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Gina Marie Allaire

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 6, 2025

Study Start

January 21, 2025

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

December 21, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)