Comparing humidity levels in incubators for extremely premature infants
Official title: Humidity in Incubators for Tiny Infants (HumidITI) Trial
Run by The University of Texas Health Science Center, Houston · NCT06399861 · Data updated 2026-11-12
This study tests whether keeping extremely premature infants in incubators with higher humidity levels can help prevent dehydration and improve their health without harming their chances of survival.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 1 Day |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 9 sites (Birmingham, Alabama and 8 other locations) |
| Status | Recruiting |
| Started | June 25, 2024 |
| Main results expected | January 15, 2030 |
| Study ends | June 1, 2030 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT06399861 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are inborn infants born at less than 25 weeks' gestation who are admitted to the NICU.
✕Probably not a fit
Patients who may not benefit from this study include those with known congenital skin conditions, outborn infants, or those with an unknown gestational age prior to birth.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates two different initial humidification protocols in incubators for infants born at less than 25 weeks' gestation who are admitted to the neonatal intensive care unit (NICU). The research compares the effects of a higher humidity level (90%) versus a lower humidity level (70%) on dehydration rates and overall health outcomes. The goal is to determine if higher humidity can reduce dehydration without negatively impacting survival or morbidity rates among these vulnerable infants.
Why it matters
Potential benefit: If successful, this study could lead to improved care protocols that enhance hydration and health outcomes for extremely premature infants.
How similar studies have gone: Other studies have explored humidification protocols in neonatal care, but this specific comparison of humidity levels is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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The University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States Recruiting -
Nationwide Children's Hospital - Grant Medical Center
Columbus, Ohio, United States Recruiting -
Nationwide Children's Hospital - Ohio State University Wexner Medical Center
Columbus, Ohio, United States Recruiting -
Children's Memorial Hermann Hospital
Houston, Texas, United States Recruiting -
Texas Children's Hospital
Houston, Texas, United States Recruiting
Show 3 more locations
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The Woman's Hospital of Texas
Houston, Texas, United States Recruiting -
St. Luke's Baptist Hospital
San Antonio, Texas, United States Recruiting -
North Central Baptist Hospital
San Antonio, Texas, United States Recruiting
Study contacts
- Principal investigator: Matthew A. Rysavy, MD, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Matthew A. Rysavy, MD, PhD
- Email: Matthew.A.Rysavy@uth.tmc.edu
- Phone: 713-500-5651
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.