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Purpose

The objective of the study is to compare different supplemental incubator humidification strategies for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The study aims to compare higher (90%) and lower (70%) starting relative humidity (RH), as well as shorter (10 days) and longer (28 days) duration of humidity supplementation.

Condition

Eligibility

Eligible Ages
Between 0 Days and 1 Day
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Inborn infant of <25 weeks' gestation admitted to the neonatal intensive care unit (NICU)

Exclusion Criteria

  • Infants with known congenital skin conditions - Outborn infants - Infants with unknown gestational age prior to birth - Infants with redirection of intensive care prior to study enrollment - Infants whose parents request not to participate

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
Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10 		Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 90% in the incubator with humidity supplementation stopped at day 10.
  • Device: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10
    Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 90% in the incubator with humidity supplementation stopped at day 10.
Active Comparator
Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 		Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 70% in the incubator with humidity supplementation stopped at day 10.
  • Device: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10
    Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 70% in the incubator with humidity supplementation stopped at day 10.
Active Comparator
Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28 		Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 90% in the incubator with humidity supplementation stopped at day 28.
  • Device: Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28
    Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 90% in the incubator with humidity supplementation stopped at day 28.
Active Comparator
Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28 		Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 70% in the incubator with humidity supplementation stopped at day 28.
  • Device: Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28
    Infants will be provided usual delivery room care and then placed in an incubator on admission to the NICU, receiving starting relative humidity (RH) of 70% in the incubator with humidity supplementation stopped at day 28.

Recruiting Locations

Children's Memorial Hermann Hospital
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.