NCT06399861|RecruitingDMCFDA Device
Humidity in Incubators for Tiny Infants
HumidITI
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Sponsor study identifier
interventional
900
1 country
9
Study Start
June 25, 2024
Actual (reported)Primary Completion
January 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2024
Actual (reported)May 6, 2024
Actual (reported)June 25, 2024
Actual (reported)January 15, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Composite safety score
A single composite safety score will be reported (mortality and 6 morbidities will be assessed to determine this score). The composite score ranges from 0 to 7, with a higher score indicating a better outcome, as listed below: * 0 = Infant does not survive * 1 = Infant survives, has all 6 assessed morbidities * 2 = Infant survives, has 5 assessed morbidities * 3 = Infant survives, has 4 assessed morbidities * 4 = Infant survives, has 3 assessed morbidities * 5 = Infant survives, has 2 assessed morbidities * 6 = Infant survives, has 1 assessed morbidities * 7 = Infant survives, has no assessed morbidities Morbidities assessed: * grade III-IV intraventricular hemorrhage (IVH) * surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP) * grade III bronchopulmonary dysplasia (BPD) * treated retinopathy of prematurity (ROP) * culture-proven late-onset sepsis (LOS) * patent ductus arteriosus (PDA) ligation
from admission to the NICU through hospital discharge (about 4-5 months)
Average axillary temperatures in degrees Celsius (°C)
daily from admission to the NICU to day 28
Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)
daily from admission to the NICU to day 28
Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)
daily from admission to the NICU to day 28
Average daily weight in grams
daily from admission to the NICU to day 28
Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)
daily from admission to the NICU to day 28
Average total pre-discharge costs
from time of admission to the NICU to discharge (about 4-5 months)
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, which is weaned to 50% by day 8, and 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, which is weaned to 50% by day 8, and 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 10.
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123, United States
Matthew A. Rysavy, MD, PhD
The University of Texas Health Science Center, Houston
First Submitted
April 26, 2024
First Posted
May 6, 2024
Study Start
June 25, 2024
Actual (reported)Primary Completion
January 15, 2030
EstimatedTrial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding
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, which is weaned to 50% by day 8, and 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, which is weaned to 50% by day 8, and 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, which is weaned to 50% by day 8, and 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, which is weaned to 50% by day 8, and 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Nationwide Children's Hospital - Grant Medical Center
Columbus, Ohio, 43205, United States
Nationwide Children's Hospital - Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
The Woman's Hospital of Texas
Houston, Texas, 77054, United States
St. Luke's Baptist Hospital
San Antonio, Texas, 78229, United States
North Central Baptist Hospital
San Antonio, Texas, 78258, United States
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 11, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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