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Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?

10. januar 2018 opdateret af: Eman Alfy Ellia, Assiut University
The aim of this study is to compare the efficacy of a single dose of intramuscular dexamethasone versus 3 days of twice-daily oral prednisolone in the management of mild to moderate asthma exacerbations in children and test whether this single dose of intramuscular dexamethasone 0.6 mg/kg (max. 18 mg) is equal to prednisolone 1 mg/kg/day (max. 40 mg) in the treatment of exacerbations of asthma in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM).

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will be performed in Assiut university Children Hospital and will include patients with asthma exacerbations presented to the emergency department for three months. All children presenting to the emergency department with mild to moderate asthma exacerbations will be assessed to decide if the child needs treatment with salbutamol. Before starting treatment the Pediatric Respiratory Assessment Measure (PRAM), vital signs, and oxygen saturation will be recorded. Peak expiratory flow rate (PEFR) will also be recorded if the patient was 6 years or older.

Children with mild to moderate asthma exacerbation will be given the first dose of salbutamol and will be reassessed after 20 min by the emergency department attending. If further salbutamol is needed, subjects automatically will receive the second dose 20 min apart and receive either single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) or oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally .

A repeat physical examination will be performed, including oxygen saturation, vital signs, PRAM, PEFR after the 3rd dose of salbutamol and at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores. Patient compliance to prednisolone therapy for three days will be also recorded.

This study will be performed in Pediatric hospital - Assiut university and will include patients with asthma exacerbations presented to the emergency department for three months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Egypten
      • Assiut, Egypten, 71511
        • Assiut University

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

2 år til 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Ages 2 to 16 years
  • Background history of asthma
  • Presentation with an asthma exacerbation requiring repeated salbutamol after 20 minutes.

Exclusion Criteria:

  • Less than 2 years old or over 16 years
  • Critical or life-threatening asthma
  • Known tuberculosis exposure
  • Active varicella or herpes simplex infection
  • Documented concurrent infection with Respiratory syncytial virus
  • Fever >39.5°C
  • Use of oral corticosteroids in the previous four weeks
  • Concurrent stridor
  • Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: dexamethasone
Dexamethasone is a long-acting glucocorticoid with a half-life of 36 to 72 hours . It has been used safely in children with croup and bacterial meningitis . It is well absorbed both orally and parenterally .Single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg).
Medicin: Dexamethasone 8Mg Solution for Injection
Effect single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) in the treatment of mild to moderate acute asthma exacerbations in children
Eksperimentel: prednisolone
Prednisolone is relatively short acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Outpatient steroid therapy is effective once compliance is assured.. Prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance with prednisolone. Oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses .
Medicin: Prednisolone Oral, Per 5 Mg
Effect of prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses in the treatment of mild to moderate acute asthma exacerbations in children.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Pediatric Respiratory Assessment Measure (PRAM)
Tidsramme: PRAM score is assessed at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores.

The Pediatric Respiratory Assessment Measure (PRAM) , a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, appears to be the most appropriate as an application in the emergency care setting .

The PRAM score consists of five components and has a maximum total of 12 points: suprasternal retractions (0 to 2), scalene muscle contraction (0 to 2), air entry (0 to 3), wheezing (0 to 3) and O2 saturation (0 to 2) .
PRAM score is assessed at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores.

Samarbejdspartnere og efterforskere

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

Sponsor

Assiut University

Efterforskere

  • Studiestol: Moustafa M. El-Saied, Ph.D.of pediatrics, Assiut University -Faculty of medecin( Pediaric department)

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)

1. januar 2017

Primær færdiggørelse (Faktiske)

30. april 2017

Studieafslutning (Forventet)

28. februar 2018

Datoer for studieregistrering

Først indsendt

22. juni 2017

Først indsendt, der opfyldte QC-kriterier

29. juni 2017

Først opslået (Faktiske)

2. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Eman Alfy Ellia

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Kliniske forsøg med Dexamethasone 8Mg Solution for Injection

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