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Recruiting NCT06399861

Humidity in Incubators for Tiny Infants

No phase Interventional Extremely Premature Infant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Incubator ambient relative humidity (RH) of 70%, Incubator ambient relative humidity (RH) of 90%.
Who it may be relevant to
Registry conditions: Extremely Premature Infant. Basic parameters: 0 Days — 1 Day · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Humidity in Incubators for Tiny Infants (HumidITI) Trial

Overview

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.

Interventions

  • Device Incubator ambient relative humidity (RH) of 70%
    The incubator will be set to an ambient relative humidity (RH) of 70%.
  • Device Incubator ambient relative humidity (RH) of 90%
    The incubator will be set to an ambient relative humidity (RH) of 90%.

Primary outcome measures

  • Efficacy as assessed by percent of birth weight lost [Time frame: upon admission to the NICU, postnatal week 2]
  • Composite safety score [Time frame: from time of admission to the NICU through hospital discharge (about 4-5 months)]
Secondary outcome measures (12)
  • Average axillary temperatures in degrees Celsius (°C) [Time frame: 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) [Time frame: 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) [Time frame: from time of admission to the NICU to postnatal day 14]
  • Average daily weight in grams [Time frame: from time of admission to the NICU to postnatal day 14]
  • 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]
  • 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]
  • 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]
  • 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]
  • Number of participants who were administered insulin [Time frame: from time of admission to the NICU to postnatal day 14]
  • Number of participants who were administered vasopressor [Time frame: from time of admission to the NICU to postnatal day 14]
  • Weight [Time frame: 36 weeks postmenstrual age]
  • Length [Time frame: 36 weeks postmenstrual age]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 6 centers
  • Nationwide Children's Hospital - Grant Medical Center — Columbus
  • Nationwide Children's Hospital - Ohio State University Wexner Medical Center — Columbus
  • Children's Memorial Hermann Hospital — Houston
  • The Woman's Hospital of Texas — Houston
  • St. Luke's Baptist Hospital — San Antonio
  • North Central Baptist Hospital — San Antonio

Identifiers

NCT: NCT06399861 · HSC-MS-24-0206

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗