- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02366715
Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research
IMLEMENTATION OF High Flow Nasal Cannulae Therapy FOR THE TREATMENT OF BRONCHIOLITIS IN A GENERAL PEDIATRIC WARD - A RETROSPECTIVE AND PROSPECTIVE CLINICAL TRIAL
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Supportive Care, Single Group Assignment, Open Label, Non-Randomized, Efficacy Study
The research is devised as follows:
Prospective section: We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents.
Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
Retrospective section: We will examine up to 200 cases of children aged 0-2 years hospitalized due to Bronchiolitis in Pediatrics C during 2014-2016 which were not enrolled in our research (due to lack of consent/unavailable HHHFNC etc.). We will compare clinical data and vital parameters between the groups treated with HHHFNC and those who were not.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Petah Tikva, Israel
- Rekrutierung
- Schneider Medical Center of Israel
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Kontakt:
- Eran Rom, MD
- Telefonnummer: +972-54-770-5626
- E-Mail: Eranr2@clalit.org.il
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
in age interval, diagnosed with Bronchiolitis
Exclusion Criteria:
Chronic heart/lung disease, immunocompromised state
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: HeatedHumidifiedHighFlowNasalCannula
Treatment for moderate-severe cases of Bronchiolitis while monitoring medical parameters
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We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co. [3] which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents. Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Changes in Bronchiolitis Severity Score grade
Zeitfenster: during the 20-40 hours of the protocol
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The grade in the Bronchiolitis Severity Score (0-12) reflects a general improvement or deterioration in any of these 5 parameters - oxygen saturation, breath rate, general appearance, degree of dyspnea and lung auscultation result.
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during the 20-40 hours of the protocol
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
CO2 pressure
Zeitfenster: during the 20-40 hours of the protocol
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(in mmHg) measured by a transcutaneous sensor.
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during the 20-40 hours of the protocol
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Medical interventions
Zeitfenster: during the 20-40 hours of the protocol
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Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics.
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during the 20-40 hours of the protocol
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Ability to take in food orally
Zeitfenster: during the 20-40 hours of the protocol
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Whether the child has been able to feed - yes or no.
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during the 20-40 hours of the protocol
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Number of Pediatric Intensive Care Unit (PICU) admissions
Zeitfenster: The whole hospitalization period of the child
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Whether the child needed admission to PICU
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The whole hospitalization period of the child
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Eran Rom, Dr., Schneider Children Medical Center of Israel
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0586-14-RMC
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