Humidity in Incubators for Tiny Infants

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06399861
Status
Recruiting
Apply to this trial

Conditions

  • Extremely Premature Infant

Eligibility Criteria

Sex
ALL
Age
0 Days - 1 Day
Healthy Volunteers
Not accepted

Interventions

  • Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10 — DEVICE
    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.
  • Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10 — DEVICE
    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.
  • Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28 — DEVICE
    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.
  • Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 28 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
May 6, 2024
Start date
Jun 25, 2024
Status verified
Aug 2026
Primary completion
Jan 15, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Composite safety score [ Time Frame: from admission to the NICU through hospital discharge (about 4-5 months) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35294
Colm Travers, MD
[email protected]
Colm Travers, MD (PRINCIPAL_INVESTIGATOR)
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Rachelle Sey, PhD, CNS, RNC-NIC
[email protected]
Katherine Coughlin, MD
[email protected]
Katherine Coughlin, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's Hospital - Grant Medical CenterColumbusOhio43205
Carl Backes, MD
[email protected]
614-722-2000
Carl Backes, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's Hospital - Ohio State University Wexner Medical CenterColumbusOhio43210
Carl Backes, MD
[email protected]
614-293-8000
Carl Backes, MD (PRINCIPAL_INVESTIGATOR)
Children's Memorial Hermann HospitalHoustonTexas77030
Matthew A. Rysavy, MD, PhD
[email protected]
713-500-5651
Matthew Rysavy, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's HospitalHoustonTexas77030
Shweta Parmekar, MD
[email protected]
Shweta Parmekar, MD (PRINCIPAL_INVESTIGATOR)
The Woman's Hospital of TexasHoustonTexas77054
Kaashif Ahmad, MD
[email protected]
Kaashif Ahmad, MD, Mac (PRINCIPAL_INVESTIGATOR)
North Central Baptist HospitalSan AntonioTexas78258
Brent Rayburn, MD
[email protected]
210-297-4000
Brent Rayburn, MD (PRINCIPAL_INVESTIGATOR)
St. Luke's Baptist HospitalSan AntonioTexas78229
Christine Aune, MD
[email protected]
210-297-5000
Christine Aune, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALSharp Mary Birch Hospital for Women & Newborns· San Diego, CANationwide Children's Hospital - Grant Medical Center· Columbus, OHNationwide Children's Hospital - Ohio State University Wexner Medical Center· Columbus, OHChildren's Memorial Hermann Hospital· Houston, TXTexas Children's Hospital· Houston, TX