Humidity in Incubators for Tiny Infants (HumidITI)

Humidity in Incubators for Tiny Infants (HumidITI) Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Extremely Premature Infant
• Intervention / Treatment: Device: Incubator ambient relative humidity (RH) of 70%; Device: Incubator ambient relative humidity (RH) of 90%

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew A. Rysavy, MD, PhD; Phone Number: 713-500-5651; Email: Matthew.A.Rysavy@uth.tmc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital - Grant Medical Center
      • Contact: Carl Backes, MD; Phone Number: 614-722-2000; Email: Carl.Backes@nationwidechildrens.org
      • Principal Investigator: Carl Backes, MD
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Nationwide Children's Hospital - Ohio State University Wexner Medical Center
      • Principal Investigator: Carl Backes, MD
      • Contact: Carl Backes, MD; Phone Number: 614-293-8000; Email: Carl.Backes@nationwidechildrens.org
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • The Woman's Hospital of Texas
      • Contact: Kaashif Ahmad, MD; Email: kahmad@uh.edu
      • Principal Investigator: Kaashif Ahmad, MD, Mac
    • Houston, Texas, United States, 77030
      • Recruiting
      • Children's Memorial Hermann Hospital
      • Contact: Matthew A. Rysavy, MD, PhD; Phone Number: 713-500-5651; Email: Matthew.A.Rysavy@uth.tmc.edu
      • Principal Investigator: Matthew Rysavy, MD
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • St. Luke's Baptist Hospital
      • Contact: Christine Aune, MD; Phone Number: 210-297-5000; Email: Christine_Aune@mednax.com
      • Principal Investigator: Christine Aune, MD
    • San Antonio, Texas, United States, 78258
      • Recruiting
      • North Central Baptist Hospital
      • Contact: Brent Rayburn, MD; Phone Number: 210-297-4000; Email: brent.reyburn@pediatrix.com
      • Principal Investigator: Brent Rayburn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Incubator ambient relative humidity (RH) of 70%; Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 70% in the incubator.	Device: Incubator ambient relative humidity (RH) of 70%; The incubator will be set to an ambient relative humidity (RH) of 70%.
Experimental: Incubator ambient relative humidity (RH) of 90%; Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving ambient relative humidity (RH) of 90% in the incubator.	Device: Incubator ambient relative humidity (RH) of 90%; The incubator will be set to an ambient relative humidity (RH) of 90%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as assessed by percent of birth weight lost		upon admission to the NICU, postnatal week 2
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 time of admission to the NICU through hospital discharge (about 4-5 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Average axillary temperatures in degrees Celsius (°C)	from time of admission to the NICU to postnatal day 3
Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)	from time of admission to the NICU to postnatal day 14
Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)	from time of admission to the NICU to postnatal day 14
Average daily weight in grams	from time of admission to the NICU to postnatal day 14
Average daily sodium administered in milliequivalents per kilogram per day (mEq/kg/d)	from time of admission to the NICU to postnatal day 14
Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)	from time of admission to the NICU to postnatal day 14
Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)	from time of admission to the NICU to postnatal day 14
Average daily protein administered in grams per kilogram per day (g/kg/d)	from time of admission to the NICU to postnatal day 14
Weight	36 weeks postmenstrual age
Length	36 weeks postmenstrual age
Head circumference	36 weeks postmenstrual age
Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)	from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)	from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with grade III bronchopulmonary dysplasia (BPD)	from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with treated retinopathy of prematurity [ROP]	from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with culture-proven late-onset sepsis (LOS)	from time of admission to the NICU to discharge (about 4-5 months)
Number of participants with patent ductus arteriosus (PDA) ligation	from time of admission to the NICU to discharge (about 4-5 months)
Number of participants who were administered insulin	from time of admission to the NICU to postnatal day 14
Number of participants who were administered vasopressor	from time of admission to the NICU to postnatal day 14
Number of participants who survive to hospital discharge	from time of admission to the NICU to discharge (about 4-5 months)
Number of unplanned removals of vascular access or breathing tube	from time of admission to the NICU to postnatal day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average total pre-discharge costs	Total pre-discharge costs (assessed from the health system perspective) encompass facility costs and professional service costs.	from time of admission to the NICU to discharge (about 4-5 months)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Matthew A. Rysavy, MD, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Humidification Protocol
• Other Study ID Numbers: HSC-MS-24-0206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No