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NCT Number: NCT06399861

Humidity in Incubators for Tiny Infants

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.

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Key information

Conditions

Extremely Premature Infant

Age range

0 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital - Grant Medical Center, Columbus, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 90%

Device

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

Primary outcomes

  1. Efficacy as assessed by percent of birth weight lost

    Time frame: upon admission to the NICU, postnatal week 2

  2. Composite safety score

    Time frame: from time of admission to the NICU through hospital discharge (about 4-5 months)

    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

Secondary outcomes

  1. Average axillary temperatures in degrees Celsius (°C)

    Time frame: from time of admission to the NICU to postnatal day 3

  2. Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)

    Time frame: from time of admission to the NICU to postnatal day 14

  3. Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)

    Time frame: from time of admission to the NICU to postnatal day 14

  4. Average daily weight in grams

    Time frame: from time of admission to the NICU to postnatal day 14

  5. Average daily sodium administered in milliequivalents per kilogram per day (mEq/kg/d)

    Time frame: from time of admission to the NICU to postnatal day 14

  6. Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)

    Time frame: from time of admission to the NICU to postnatal day 14

  7. Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)

    Time frame: from time of admission to the NICU to postnatal day 14

  8. Average daily protein administered in grams per kilogram per day (g/kg/d)

    Time frame: from time of admission to the NICU to postnatal day 14

  9. Number of participants who were administered insulin

    Time frame: from time of admission to the NICU to postnatal day 14

  10. Number of participants who were administered vasopressor

    Time frame: from time of admission to the NICU to postnatal day 14

  11. Weight

    Time frame: 36 weeks postmenstrual age

  12. Length

    Time frame: 36 weeks postmenstrual age

  13. Head circumference

    Time frame: 36 weeks postmenstrual age

  14. Number of participants who survive to hospital discharge

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

  15. Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)

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

  16. Number of participants with necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)

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

  17. Number of participants with grade III bronchopulmonary dysplasia (BPD)

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

  18. Number of participants with treated retinopathy of prematurity [ROP]

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

  19. Number of participants with culture-proven late-onset sepsis (LOS)

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

  20. Number of participants with patent ductus arteriosus (PDA) ligation

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

  21. Number of unplanned removals of vascular access or breathing tube

    Time frame: from time of admission to the NICU to postnatal day 14

Other outcomes

  1. Average total pre-discharge costs

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

    Total pre-discharge costs (assessed from the health system perspective) encompass facility costs and professional service costs.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew A. Rysavy, MD, PhD

CONTACT

[email protected]

713-500-5651

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Humidity in Incubators for Tiny Infants (HumidITI) Trial

Acronym: HumidITI

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 6, 2024
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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