Humidity in Incubators for Tiny Infants

NCT06399861 | Recruiting DMC FDA Device

• 1 other identifier: HSC-MS-24-0206
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 6

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.

Conditions

Extremely Premature Infant

Keywords

Humidification Protocol

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• 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

Other Outcomes (1)

• Average total pre-discharge costs

  from time of admission to the NICU to discharge (about 4-5 months)

Study Arms (2)

Incubator ambient relative humidity (RH) of 70%

ACTIVE COMPARATOR

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%

Incubator ambient relative humidity (RH) of 90%

EXPERIMENTAL

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%

Interventions

Incubator ambient relative humidity (RH) of 70% DEVICE

The incubator will be set to an ambient relative humidity (RH) of 70%.

Incubator ambient relative humidity (RH) of 70%

Incubator ambient relative humidity (RH) of 90% DEVICE

The incubator will be set to an ambient relative humidity (RH) of 90%.

Incubator ambient relative humidity (RH) of 90%

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Inborn infant of \<25 weeks' gestation admitted to the NICU

You may not qualify if:

• Infants with known congenital skin conditions
• Outborn infants
• Infants with unknown gestational age prior to birth

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (6)

Nationwide Children's Hospital - Grant Medical Center

Columbus, Ohio, 43205, United States

RECRUITING

Nationwide Children's Hospital - Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

The Woman's Hospital of Texas

Houston, Texas, 77054, United States

RECRUITING

St. Luke's Baptist Hospital

San Antonio, Texas, 78229, United States

RECRUITING

North Central Baptist Hospital

San Antonio, Texas, 78258, United States

RECRUITING

Study Officials

• Matthew A. Rysavy, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew A. Rysavy, MD, PhD

CONTACT

713-500-5651; Matthew.A.Rysavy@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 6, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)