Effekt af at bruge ilt på bledermatitis hos spædbørn
20. september 2023 opdateret af: Elif Dogan, Istanbul University - Cerrahpasa (IUC)
Baggrund: Udluftning af bleområdet har en positiv effekt på dermatitis. Derudover er det rapporteret i litteraturen, at oxygen er effektivt til sårpleje. Formålet med vores undersøgelse er at undersøge effekten af ilt på babyble-dermatitis.
Metode: Undersøgelsespopulationen bestod af spædbørn, der vil blive indlagt på neonatal intensivafdeling på et offentligt hospital i Istanbul mellem maj 2022 og september 2022. Tres nyfødte, der opfyldte undersøgelseskriterierne, vil randomisere og opdele i to som forsøgs- (n=30) og kontrol- (n=30) grupper. Persondataskema og bleeksem-observationsskema vil blive brugt til at indhente dataene. Alle babyers bleer bliver skiftet 8 gange om dagen. Oxygenflow vil blive påført forsøgsgruppen i en time efter hvert bleskift. Graden af bledermatitis vil blive evalueret hver 24. time.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
103
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul, Kalkun
- Istanbul University Cerrahpasa
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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
1 år til 1 år (Barn)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Godkendt af familien til undersøgelsen
- Født mellem 34-42. svangerskabsuger
- Ingen hudsygdom udover bleeksem
- Ingen hudlæsioner af anden sygdom end dermatitis-relaterede læsioner i kirtelområdet
- Nyfødte, der har stabile vitale tegn
Ekskluderingskriterier:
- Har en anden hudsygdom end bleeksem
- At have en læsion på huden på grund af en anden sygdom
- At have en kendt hudallergi
- Født før 34. svangerskabsuger
- At have en mave-tarmsygdom
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Oxygen gruppe
Efter babyens ble er skiftet, vil en iltslange placeret inde i bleen give fri iltstrøm til bleområdet. Ilt påføres i 1 time ved hvert bleskift med en flowhastighed på 5L/min og med en koncentration på 21% FiO2, hvilket svarer til rumluft. |
Efter bleen er skiftet, vil der blive givet fri flow ilt til bleområdet i 1 time med en iltkanyle placeret inde i bleen (iltflow er %21 Fio2, 5 L/min)
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Ingen indgriben: Kontrolgruppe
Denne gruppe vil kun modtage rutinepleje: Ble skiftes ved hjælp af engangsvådservietter og engangsbarneble. En barrierecreme indeholdende 40 % zinkoxid påføres det rensede bleområde som et tyndt lag for at dække huden. Babyens bleskift vil blive lavet 8 gange om dagen hver tredje time. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ble dermatitis helbredende skala resultat
Tidsramme: 72 timer
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Forventer at helbrede ble dermatitis symptomer på tidspunktet for intervention.
Skalaens maksimumværdi: 6 og minimumsværdi: 0. Efterhånden som skalaens score stiger, øges sværhedsgraden af dermatitis.
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72 timer
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Elif Dogan, Researcher Assistant
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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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)
15. oktober 2022
Primær færdiggørelse (Faktiske)
15. marts 2023
Studieafslutning (Faktiske)
15. april 2023
Datoer for studieregistrering
Først indsendt
14. juni 2022
Først indsendt, der opfyldte QC-kriterier
16. juni 2022
Først opslået (Faktiske)
22. juni 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2023
Sidst verificeret
1. september 2023
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