Comparing humidity levels in incubators for extremely premature infants
Humidity in Incubators for Tiny Infants (HumidITI) Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 0 Days to 1 Day |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 6 sites (Columbus, Ohio and 5 other locations) |
| Trial ID | NCT06399861 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are inborn infants born at less than 25 weeks' gestation who are admitted to the NICU.
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.
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 performed: Other studies have explored humidification protocols in neonatal care, but this specific comparison of humidity levels is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbus, Ohio and 5 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.