Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT06399861
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2024-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Humidity in Incubators for Tiny Infants
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Humidity in Incubators for Tiny Infants (HumidITI) Trial
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HumidITI
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: