Nebulized Hypertonic Saline for Bronchiolitis
Observational Study on the Use of Hypertonic Saline for the Treatment of Bronchiolitis
In randomized controlled trials, the use of nebulized hypertonic saline in acute bronchiolitis has been reported to improve respiratory distress scores, to reduce length of hospital stay and to show a trend towards lower hospitalization rates.
The investigators aim to verify by an observational study if the rate of hospital admission and the length of hospital stay of infants presenting to the emergency department (ED) with bronchiolitis decreases after the inclusion of 5.85% nebulized hypertonic saline in the treatment strategy of the ED and hospitalization wards.
The investigators will assess the evolution of hospital admission rates and the length of hospital stay in two hospitals that use 5.85% nebulized hypertonic saline for the treatment of bronchiolitis and in two hospital that do not use these nebulizations. If nebulized hypertonic saline is effective in this setting, then the hospitalization rates and length of stay should be lower during the year of hypertonic saline use compared to two previous years when this therapy was not used. These parameters would not be modified in centers that do not use hypertonic saline.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This is a before-after observational study designed to compare the results in terms of hospitalization rate and length of hospital stay between a period when nebulized hypertonic saline was included in the treatment of bronchiolitis in infants versus the two previous years when this therapy was not used in two hospitals. There will not be any randomization.
Physicians have been instructed on the use of hypertonic saline for moderate and severe bronchiolitis in infants but its totally up to them whether to use this nebulization for each particular patient. Two other hospital where nebulized hypertonic saline has never been used and will not be used during the next bronchiolitis epidemics will be the control centers.
The study comprises two periods, one prospective starting on November 2011 and ending in March 2012 and one retrospective including the two previous bronchiolitis epidemics, November 2009-March 2012 and November 2010-March 2011.
During the prospective period a standardized assessment of the respiratory status of each infant will be carried out before and after each hypertonic saline nebulization.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Le Chesnay, Frankrike, 78157
- Hopital de Versailles
-
Paris, Frankrike, 75019
- Hôpital Robert Debré
-
Paris, Frankrike, 75012
- Hôpital Armand Trousseau
-
Poissy, Frankrike, 78300
- Chi Poissy Saint Germain En Laye
-
-
Ile-de-France
-
Bondy, Ile-de-France, Frankrike, 93143
- Hôpital Jean Verdier
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- All infants up to 1 year of age presenting to the ED for bronchiolitis during the study periods.
Exclusion Criteria:
- Bronchiolitis in infants older than 1 year
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospitalization rate
Tidsramme: 6 MONTHS
|
Comparison of hospitalization rates of infants presenting to the ED with bronchiolitis during the year of use of nebulized hypertonic saline versus the two previous years when nebulized hypertonic saline was not used.
|
6 MONTHS
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of hospital stay
Tidsramme: 6 months
|
Comparison of lenghts of stay of infants hospitalized for bronchiolitis during the year of use of nebulized hypertonic saline in hospitalization wards versus the two previous years when nebulized hypertonic saline was not used.
|
6 months
|
|
Assessment of 5.85% hypertonic saline tolerance
Tidsramme: 6 months
|
A standardized assessment of the respiratory status will be carried out right before and after each nebulization
|
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ricardo Carbajal, MD, PhD, Hôpital Armand Trousseau, Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Bronchiolitis-saline
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Bronkiolitt
-
University Hospital, Basel, SwitzerlandRekrutteringBronchiolitis Obliterans Syndrome (BOS) | Bronchiolitis Obliterans (BO)Sveits, Saudi-Arabia
-
Washington University School of MedicineThe Foundation for Barnes-Jewish Hospital; Mallinckrodt; Centers for Medicare...Aktiv, ikke rekrutterendeBronchiolitis Obliterans Syndrome (BOS)Forente stater
-
Children's Hospital Medical Center, CincinnatiRekrutteringBronchiolitis Obliterans (BO) | Hematopoetisk stamcelletransplantasjon (HSCT)Forente stater
-
Renovion, Inc.RekrutteringPre-Bronchiolitis Obliterans syndromForente stater
-
University of ChicagoFullførtBronchiolitis Obliterans syndromForente stater
-
Zambon SpAAvsluttetStamcelletransplantasjonskomplikasjoner | GVHD, kronisk | Bronchiolitis Obliterans Syndrome (BOS)Spania, Frankrike, Tyskland
-
University Hospital RegensburgClinAssess GmbHUkjentSteroid-refraktær Bronchiolitis ObliteransTyskland
-
Incyte CorporationAktiv, ikke rekrutterendeKronisk graft versus vertssykdom | Myelofibrose | Postlungetransplantasjon (Bronchiolitis Obliterans)Forente stater, Spania, Italia, Tyskland, Belgia, Østerrike, Israel, Canada, Hellas
-
Rigshospitalet, DenmarkFullførtLidelse relatert til lungetransplantasjon | CLAD, Bronchiolitis ObliteransStorbritannia, Belgia, Danmark, Tyskland, Nederland, Norge, Sverige
-
Hopital FochFullførtBronchiolitis Obliterans syndromFrankrike