Humidity in Incubators for Tiny Infants (HumidITI)

Humidity in Incubators for Tiny Infants (HumidITI) Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Extremely Premature Infant
• Intervention / Treatment: Device: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10; Device: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10; Device: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28; Device: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28

• Study Type: Interventional
• Enrollment (Estimated): 900
• 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
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • The University of Alabama at Birmingham
      • Principal Investigator: Colm Travers, MD
      • Contact: Colm Travers, MD; Email: cptravers@uabmc.edu
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Sharp Mary Birch Hospital for Women & Newborns
      • Contact: Rachelle Sey, PhD, CNS, RNC-NIC; Email: Rachelle.Sey@sharp.com
      • Contact: Katherine Coughlin, MD; Email: katherine.coughlin@sharp.com
      • Principal Investigator: Katherine Coughlin, MD
  • 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, 77030
      • Recruiting
      • Texas Children's Hospital
      • Principal Investigator: Shweta Parmekar, MD
      • Contact: Shweta Parmekar, MD; Email: Shweta.Parmekar@bcm.edu
    • 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 Reyburn, MD; Phone Number: 210-297-4000; Email: brent.reyburn@pediatrix.com
      • Principal Investigator: Brent Reyburn, 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 neonatal intensive care unit (NICU)

Exclusion Criteria:

• Infants with known congenital skin conditions
• Outborn infants
• Infants with unknown gestational age prior to birth
• Infants with redirection of intensive care prior to study enrollment
• Infants whose parents request not to participate

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Higher (90%) starting RH in the incubator with 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.	Device: Higher (90%) starting RH in the incubator with 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.
Active Comparator: Lower (70%) starting RH in the incubator with 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.	Device: Lower (70%) starting RH in the incubator with 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.
Active Comparator: Higher (90%) starting RH in the incubator with 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 90% in the incubator, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.	Device: Higher (90%) starting RH in the incubator with 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 90% in the incubator, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.
Active Comparator: Lower (70%) starting RH in the incubator with 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.	Device: Lower (70%) starting RH in the incubator with 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Highest serum creatinine level in in mg/dL	from admission to the NICU to postnatal day 28
Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)	daily from admission to the NICU to day 28
Average daily protein administered in grams per kilogram per day (g/kg/d)	daily from admission to the NICU to day 28
Number of participants who were administered insulin	from admission to the NICU to postnatal day 28
Number of participants who were administered vasopressor	from admission to the NICU to postnatal day 28
Number of unplanned removals of vascular access or breathing tube	from admission to the NICU to postnatal day 28
Weight in grams	36 weeks postmenstrual age
Length in centimeters	36 weeks postmenstrual age
Head circumference in centimeters	36 weeks postmenstrual age
Number of participants who survive to hospital discharge	from admission to the NICU to discharge (about 4-5 months)
Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)	from admission to the NICU to discharge (about 4-5 months)
Number of participants with grade III bronchopulmonary dysplasia (BPD)	from admission to the NICU to discharge (about 4-5 months)
Number of participants with treated retinopathy of prematurity [ROP]	from admission to the NICU to discharge (about 4-5 months)
Number of participants with culture-proven late-onset sepsis (LOS)	from admission to the NICU to discharge (about 4-5 months)
Number of participants with patent ductus arteriosus (PDA) ligation	from admission to the NICU to discharge (about 4-5 months)
Number of participants with surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)	from admission to the NICU to discharge (about 4-5 months)

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): January 15, 2030
• Study Completion (Estimated): June 1, 2030

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 (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

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