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

NCT ID: NCT06958003

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-21

Study Completion Date

2027-04-21

Brief Summary

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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

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Conditions

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Diaper Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Air Therapy

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

Group Type EXPERIMENTAL

Air Therapy

Intervention Type OTHER

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

Routine Care

Patients will receive routine diaper care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Air Therapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gina Marie Allaire

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

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Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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24-091

Identifier Type: -

Identifier Source: org_study_id

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