Recruiting

Humidity Protocols

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06399861

Conditions

Extremely Premature Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

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

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

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

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

Study Details

Brief 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.

Conditions

Extremely Premature Infant

Study ID

NCT06399861

Start date

Jun 25, 2024

Status verified date

Aug, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jan 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inborn infant of <25 weeks' gestation admitted to the neonatal intensive care unit (NICU)

Exclusion Criteria:

  • Infants with known congenital skin conditions
  • Outborn infants
  • Infants with unknown gestational age prior to birth
  • Infants with redirection of intensive care prior to study enrollment
  • Infants whose parents request not to participate

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

active comparator: 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.

active comparator: 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.

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Composite safety score [ Time Frame: from admission to the NICU through hospital discharge (about 4-5 months) ]

Central Contacts and Locations

Central contacts

Matthew A. Rysavy, MD, PhD

713-500-5651Matthew.A.Rysavy@uth.tmc.edu

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Colm Travers, MD

cptravers@uabmc.edu

Principal Investigator:

Colm Travers, MD

Sharp Mary Birch Hospital for Women & Newborns

Recruiting

San Diego, California, United States, 92123

Contacts

Rachelle Sey, PhD, CNS, RNC-NIC

Rachelle.Sey@sharp.com

Katherine Coughlin, MD

katherine.coughlin@sharp.com

Principal Investigator:

Katherine Coughlin, MD

Nationwide Children's Hospital - Grant Medical Center

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Carl Backes, MD

614-722-2000Carl.Backes@nationwidechildrens.org

Principal Investigator:

Carl Backes, MD

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

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Carl Backes, MD

614-293-8000Carl.Backes@nationwidechildrens.org

Principal Investigator:

Carl Backes, MD

Children's Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Matthew A. Rysavy, MD, PhD

713-500-5651Matthew.A.Rysavy@uth.tmc.edu

Principal Investigator:

Matthew Rysavy, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Shweta Parmekar, MD

Shweta.Parmekar@bcm.edu

Principal Investigator:

Shweta Parmekar, MD

The Woman's Hospital of Texas

Recruiting

Houston, Texas, United States, 77054

Contacts

Kaashif Ahmad, MD

kahmad@uh.edu

Principal Investigator:

Kaashif Ahmad, MD, Mac

St. Luke's Baptist Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Christine Aune, MD

210-297-5000Christine_Aune@mednax.com

Principal Investigator:

Christine Aune, MD

North Central Baptist Hospital

Recruiting

San Antonio, Texas, United States, 78258

Contacts

Brent Reyburn, MD

210-297-4000brent.reyburn@pediatrix.com

Principal Investigator:

Brent Reyburn, MD

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Humidification Protocol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-09-01.