Humidity in Incubators for Tiny Infants

Conditions

• Extremely Premature Infant

Eligibility Criteria

Sex

ALL

Age

0 Days - 1 Day

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Jun 25, 2024

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Jul 1, 2027

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Incubator ambient relative humidity (RH) of 70%
  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.
• Experimental: Incubator ambient relative humidity (RH) of 90%
  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.

Primary Outcome Measure

Efficacy as assessed by percent of birth weight lost [ Time Frame: upon admission to the NICU, postnatal week 2 ]

Central Contacts

• Matthew A. Rysavy, MD, PhD
  713-500-5651
  [email protected]

Locations (6)

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