Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Pr... | NCT06958003

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

NCT06958003

Sponsor

TriHealth Inc.

Status

Enrolling by invitation

Last Update Posted

Feb 17, 2026Actual

Enrollment

320Estimated

Phase

Not Applicable

Conditions

Diaper Dermatitis

Interventions

Air Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2025Actual

Primary Completion Date

Jul 21, 2027Estimated

Completion Date

Dec 21, 2027Estimated

First Submitted Date

Apr 21, 2025

First Submission Date that Met QC Criteria

May 2, 2025

First Posted Date

May 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Air Therapy	Other	3-5 minutes of air therapy in addition to routine diaper care	Air Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Weeks

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gina Marie Allaire	TriHealth Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Good Samaritan Hospital		Cincinnati	Ohio	45220	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003963	Diaper Rash

Ancestor Terms

ID	Term
D017453	Dermatitis, Irritant
D003877	Dermatitis, Contact
D003872	Dermatitis
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided