Trials / Recruiting
RecruitingNCT06399861
Humidity in Incubators for Tiny Infants
Humidity in Incubators for Tiny Infants (HumidITI) Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- All
- Age
- 0 Days – 1 Day
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Incubator ambient relative humidity (RH) of 70% | The incubator will be set to an ambient relative humidity (RH) of 70%. |
| DEVICE | Incubator ambient relative humidity (RH) of 90% | The incubator will be set to an ambient relative humidity (RH) of 90%. |
Timeline
- Start date
- 2024-06-25
- Primary completion
- 2026-12-31
- Completion
- 2027-07-01
- First posted
- 2024-05-06
- Last updated
- 2025-10-29
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06399861. Inclusion in this directory is not an endorsement.