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RECRUITING
NCT06399861
NA

Humidity in Incubators for Tiny Infants

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

The objective of the study is to compare different supplemental incubator humidification strategies for infants \<25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The study aims to compare higher (90%) and lower (70%) starting relative humidity (RH), as well as shorter (10 days) and longer (28 days) duration of humidity supplementation.

Official title: Humidity in Incubators for Tiny Infants (HumidITI) Trial (Stage 1)

Key Details

Gender

All

Age Range

0 Days - 1 Day

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2024-06-25

Completion Date

2030-06-01

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

DEVICE

Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10

Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 90% in the incubator with humidity supplementation stopped at day 10.

DEVICE

Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10

Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 70% in the incubator with humidity supplementation stopped at day 10.

DEVICE

Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28

Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 90% in the incubator with humidity supplementation stopped at day 28.

DEVICE

Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28

Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 70% in the incubator with humidity supplementation stopped at day 28.

Locations (9)

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States

Nationwide Children's Hospital - Grant Medical Center

Columbus, Ohio, United States

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

Columbus, Ohio, United States

Children's Memorial Hermann Hospital

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

The Woman's Hospital of Texas

Houston, Texas, United States

St. Luke's Baptist Hospital

San Antonio, Texas, United States

North Central Baptist Hospital

San Antonio, Texas, United States