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Fugtighed i kuvøser til små spædbørn (HumidITI)

8. september 2026 opdateret af: Matthew Rysavy, The University of Texas Health Science Center, Houston

Forsøg med fugtighed i kuvøse til små spædbørn (HumidITI).

Formålet med undersøgelsen er at vurdere 2 forskellige initiale inkubatorbefugtningsprotokoller for spædbørn <25 ugers graviditet indlagt på neonatal intensiv afdeling (NICU). Hypotesen er, at en højere startfugtighed mindsker dehydrering og resulterer ikke i nogen forskel i overlevelse eller sygelighed. Højere (90%) og lavere (70%) startfugtighed vil blive sammenlignet.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

900

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Rekruttering
        • The University of Alabama at Birmingham
        • Ledende efterforsker:
          • Colm Travers, MD
        • Kontakt:
    • California
      • San Diego, California, Forenede Stater, 92123
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43205
        • Rekruttering
        • Nationwide Children's Hospital - Grant Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Carl Backes, MD
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • Nationwide Children's Hospital - Ohio State University Wexner Medical Center
        • Ledende efterforsker:
          • Carl Backes, MD
        • Kontakt:
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Texas Children's Hospital
        • Ledende efterforsker:
          • Shweta Parmekar, MD
        • Kontakt:
      • Houston, Texas, Forenede Stater, 77054
        • Rekruttering
        • The Woman's Hospital of Texas
        • Kontakt:
        • Ledende efterforsker:
          • Kaashif Ahmad, MD, Mac
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • Children's Memorial Hermann Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Matthew Rysavy, MD
      • San Antonio, Texas, Forenede Stater, 78229
        • Rekruttering
        • St. Luke's Baptist Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christine Aune, MD
      • San Antonio, Texas, Forenede Stater, 78258
        • Rekruttering
        • North Central Baptist Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Brent Reyburn, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Medfødt spædbarn <25 ugers svangerskab indlagt på NICU

Ekskluderingskriterier:

  • Spædbørn med kendte medfødte hudsygdomme
  • Udfødte spædbørn
  • Spædbørn med ukendt gestationsalder før fødslen

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 10.
Enhed: 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 10.
Aktiv komparator: 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 10.
Enhed: 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 10.
Aktiv komparator: 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.
Enhed: 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.
Aktiv komparator: 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.
Enhed: 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, which is weaned to 50% by day 8, and humidity supplementation stopped at day 28.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite safety score
Tidsramme: from admission to the NICU through hospital discharge (about 4-5 months)

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 morbidities
  • 6 = Infant survives, has 1 assessed morbidities
  • 7 = Infant survives, has no assessed morbidities

Morbidities assessed:

  • grade III-IV intraventricular hemorrhage (IVH)
  • surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)
  • grade III bronchopulmonary dysplasia (BPD)
  • treated retinopathy of prematurity (ROP)
  • culture-proven late-onset sepsis (LOS)
  • patent ductus arteriosus (PDA) ligation
from admission to the NICU through hospital discharge (about 4-5 months)

Sekundære resultatmål

Resultatmål
Tidsramme
Average axillary temperatures in degrees Celsius (°C)
Tidsramme: daily from admission to the NICU to day 28
daily from admission to the NICU to day 28
Average daily total fluid intake in milliliters per kilogram per day (mL/kg/d)
Tidsramme: daily from admission to the NICU to day 28
daily from admission to the NICU to day 28
Average daily total fluid output in milliliters per kilogram per day (mL/kg/d)
Tidsramme: daily from admission to the NICU to day 28
daily from admission to the NICU to day 28
Average daily weight in grams
Tidsramme: daily from admission to the NICU to day 28
daily from admission to the NICU to day 28
Average daily serum sodium in milliequivalents per liter per day (mEq/L/d)
Tidsramme: daily from admission to the NICU to day 28
daily from admission to the NICU to day 28
Highest serum creatinine level in in mg/dL
Tidsramme: from admission to the NICU to postnatal day 28
from admission to the NICU to postnatal day 28
Average daily calories administered in kilocalories per kilogram per day (kcal/kg/d)
Tidsramme: daily from admission to the NICU to day 28
daily from admission to the NICU to day 28
Average daily protein administered in grams per kilogram per day (g/kg/d)
Tidsramme: daily from admission to the NICU to day 28
daily from admission to the NICU to day 28
Number of participants who were administered insulin
Tidsramme: from admission to the NICU to postnatal day 28
from admission to the NICU to postnatal day 28
Number of participants who were administered vasopressor
Tidsramme: from admission to the NICU to postnatal day 28
from admission to the NICU to postnatal day 28
Number of unplanned removals of vascular access or breathing tube
Tidsramme: from admission to the NICU to postnatal day 28
from admission to the NICU to postnatal day 28
Weight in grams
Tidsramme: 36 weeks postmenstrual age
36 weeks postmenstrual age
Length in centimeters
Tidsramme: 36 weeks postmenstrual age
36 weeks postmenstrual age
Head circumference in centimeters
Tidsramme: 36 weeks postmenstrual age
36 weeks postmenstrual age
Number of participants who survive to hospital discharge
Tidsramme: from admission to the NICU to discharge (about 4-5 months)
from admission to the NICU to discharge (about 4-5 months)
Number of participants with severe (grade III-IV) intraventricular hemorrhage (IVH)
Tidsramme: from admission to the NICU to discharge (about 4-5 months)
from admission to the NICU to discharge (about 4-5 months)
Number of participants with grade III bronchopulmonary dysplasia (BPD)
Tidsramme: from admission to the NICU to discharge (about 4-5 months)
from admission to the NICU to discharge (about 4-5 months)
Number of participants with treated retinopathy of prematurity [ROP]
Tidsramme: from admission to the NICU to discharge (about 4-5 months)
from admission to the NICU to discharge (about 4-5 months)
Number of participants with culture-proven late-onset sepsis (LOS)
Tidsramme: from admission to the NICU to discharge (about 4-5 months)
from admission to the NICU to discharge (about 4-5 months)
Number of participants with patent ductus arteriosus (PDA) ligation
Tidsramme: from admission to the NICU to discharge (about 4-5 months)
from admission to the NICU to discharge (about 4-5 months)
Number of participants with surgical necrotizing enterocolitis (NEC) or focal intestinal perforation (FIP)
Tidsramme: from admission to the NICU to discharge (about 4-5 months)
from admission to the NICU to discharge (about 4-5 months)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gennemsnitlige samlede omkostninger til forladning
Tidsramme: Fra adgangstidspunktet i NICU til udledning (ca. 4-5 måneder)
De samlede omkostninger til forladning (vurderet ud fra sundhedssystemets perspektiv) omfatter omkostninger og professionelle serviceomkostninger.
Fra adgangstidspunktet i NICU til udledning (ca. 4-5 måneder)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center, Houston

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. juni 2024

Primær færdiggørelse (Anslået)

15. januar 2030

Studieafslutning (Anslået)

1. juni 2030

Datoer for studieregistrering

Først indsendt

26. april 2024

Først indsendt, der opfyldte QC-kriterier

2. maj 2024

Først opslået (Faktiske)

6. maj 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HSC-MS-24-0206

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Ja

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Ingen

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