Humidity in Incubators for Tiny Infants (HumidITI)

The University of Texas System (UT)

Status: Enrolling

Conditions: Extremely Premature Infant

Treatments: Device: Incubator ambient relative humidity (RH) of 90%; Device: Incubator ambient relative humidity (RH) of 70%

Study type: Interventional

Funder types: Other

Identifiers

NCT06399861

HSC-MS-24-0206

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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350 participants in 2 patient groups

Incubator ambient relative humidity (RH) of 70%

Active Comparator group

Description:

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.

Treatment:

Device: Incubator ambient relative humidity (RH) of 70%

Incubator ambient relative humidity (RH) of 90%

Experimental group

Description:

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.

Treatment:

Device: Incubator ambient relative humidity (RH) of 90%