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Purpose

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.

Condition

Eligibility

Eligible Ages
Under 1 Day
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

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

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Matthew A. Rysavy, MD, PhD
713-500-5651
Matthew.A.Rysavy@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Matthew A. Rysavy, MD, PhD
713-500-5651
Matthew.A.Rysavy@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.