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NCT06399861 · ClinicalTrials.gov registry record · NA

Humidity in Incubators for Tiny Infants

A NA study of Extremely Premature Infant, sponsored by The University of Texas Health Science Center, Houston.

Recruiting
Registry status
NA
Development phase
350
Enrollment target
6
Study locations

NCT06399861: Recruiting NA study of Extremely Premature Infant, sponsored by The University of Texas Health Science Center, Houston.

NCT06399861 is a NA study of Extremely Premature Infant that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 350 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06399861, a NA study of Extremely Premature Infant, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.

RECRUITING
Registry status
NA
Development phase
350 participants
Enrollment target
6
Study locations

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.

Primary Outcome

A single composite safety score will be reported (mortality and 6 morbidities will be assessed to determine this score). The composite score ranges from 0 to 7, with a higher score indicating a better outcome, as listed below: * 0 = Infant does not survive * 1 = Infant survives, has all 6 assessed morbidities * 2 = Infant survives, has 5 assessed morbidities * 3 = Infant survives, has 4 assessed morbidities * 4 = Infant survives, has 3 assessed morbidities * 5 = Infant survives, has 2 assessed

Conditions Studied

Interventions

  • DEVICE Incubator ambient relative humidity (RH) of 70%
  • DEVICE Incubator ambient relative humidity (RH) of 90%

Study Locations (6)

Texas

  • Children's Memorial Hermann Hospital - Houston
  • The Woman's Hospital of Texas - Houston
  • St. Luke's Baptist Hospital - San Antonio
  • North Central Baptist Hospital - San Antonio

Ohio

  • Nationwide Children's Hospital - Grant Medical Center - Columbus
  • Nationwide Children's Hospital - Ohio State University Wexner Medical Center - Columbus

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2024-06-25
Est. Completion 2027-07-01
Phase NA

What NCT06399861 shows while recruiting

NCT06399861 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).

The record links to 1 condition, with Extremely Premature Infant appearing as the primary indexed condition, and to 2 interventions - of which Incubator ambient relative humidity (RH) of 70% is the first listed.

NCT06399861 lists 6 locations in 2 states (Texas, Ohio).

Frequently Asked Questions

What is clinical trial NCT06399861 about?

NCT06399861 is a clinical study titled "Humidity in Incubators for Tiny Infants". 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 mo...

What is the current status of trial NCT06399861?

This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2024-06-25. Estimated completion is 2027-07-01.

What conditions does trial NCT06399861 study?

This clinical trial studies the following conditions: Extremely Premature Infant.

What interventions are being tested in trial NCT06399861?

The interventions under investigation include: Incubator ambient relative humidity (RH) of 70% (DEVICE), Incubator ambient relative humidity (RH) of 90% (DEVICE).

Who is sponsoring clinical trial NCT06399861?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06399861 being conducted?

This trial has 6 study locations across Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06399861's enrollment target sits among peer trials

350 292nd of 2000 higher than 1,699 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06399861, the US trial registry maintained by the National Library of Medicine. NCT06399861 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.