Humidity in Incubators for Tiny Infants

NCT ID: NCT06399861

Last Updated: 2025-10-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2027-07-01

Brief Summary

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The objective of the study is to assess 2 different initial incubator humidification protocols for infants \<25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared.

Detailed Description

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Conditions

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Extremely Premature Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Incubator ambient relative humidity (RH) of 70%

Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 70% in the incubator.

Group Type ACTIVE_COMPARATOR

Incubator ambient relative humidity (RH) of 70%

Intervention Type DEVICE

The incubator will be set to an ambient relative humidity (RH) of 70%.

Incubator ambient relative humidity (RH) of 90%

Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 90% in the incubator.

Group Type EXPERIMENTAL

Incubator ambient relative humidity (RH) of 90%

Intervention Type DEVICE

The incubator will be set to an ambient relative humidity (RH) of 90%.

Interventions

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Incubator ambient relative humidity (RH) of 70%

The incubator will be set to an ambient relative humidity (RH) of 70%.

Intervention Type DEVICE

Incubator ambient relative humidity (RH) of 90%

The incubator will be set to an ambient relative humidity (RH) of 90%.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Inborn infant of \<25 weeks' gestation admitted to the NICU

Exclusion Criteria

* Infants with known congenital skin conditions
* Outborn infants
* Infants with unknown gestational age prior to birth
Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Matthew Rysavy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew A. Rysavy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Nationwide Children's Hospital - Grant Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital - Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

Children's Memorial Hermann Hospital

Houston, Texas, United States

Site Status RECRUITING

The Woman's Hospital of Texas

Houston, Texas, United States

Site Status RECRUITING

St. Luke's Baptist Hospital

San Antonio, Texas, United States

Site Status RECRUITING

North Central Baptist Hospital

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matthew A. Rysavy, MD, PhD

Role: CONTACT

713-500-5651

Facility Contacts

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Carl Backes, MD

Role: primary

614-722-2000

Carl Backes, MD

Role: primary

614-293-8000

Matthew A. Rysavy, MD, PhD

Role: primary

713-500-5651

Kaashif Ahmad, MD

Role: primary

Christine Aune, MD

Role: primary

210-297-5000

Brent Rayburn, MD

Role: primary

210-297-4000

Other Identifiers

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HSC-MS-24-0206

Identifier Type: -

Identifier Source: org_study_id

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