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Humidity in Incubators for Tiny Infants

NCT06399861 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-10-29

No results posted yet for this study

Summary

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.

Conditions

  • Extremely Premature Infant

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%.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Matthew A. Rysavy, MD, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2026-12-31
Completion
2027-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06399861 on ClinicalTrials.gov