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Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis

12. maj 2008 opdateret af: Princess Margaret Hospital for Children

A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis

Home oxygen therapy is considered an appropriate and relatively safe option for children with chronic respiratory problems such as chronic lung disease of prematurity, but the use of home oxygen therapy for children with acute respiratory problems is limited. With the recent establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to determine the safety, parental satisfaction and economic advantage of home oxygen therapy for children with acute bronchiolitis compared with traditional inpatient hospitalization.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Acute bronchiolitis is the most common reason for hospital admission in children aged less than 1 year in developed countries. Over the last 25 years, hospitalization rates and admission duration have increased dramatically, resulting in substantial health care costs for both institutions and individual families.

There are currently no pharmacological therapies for acute bronchiolitis that have been shown to consistently alter the natural history of this disease. Current evidence suggests that management is essentially supportive, consisting of oxygen supplementation if the child is hypoxic and nasogastric feeds or intravenous fluids if the child is dehydrated. Oxygen supplementation is the principal determinant of the length of hospital admission for children with acute bronchiolitis and the need for supplemental oxygen is generally considered to be an absolute indication for hospitalization. However, Bajaj et al demonstrated that a carefully selected population of children with acute bronchiolitis can be managed safely with home oxygen therapy.

The escalating demand and cost of health care has driven health reforms in many countries, including Australia and the United Kingdom. These reforms have included the development of services that allow patients with a range of illnesses to be managed safely in their own home rather than hospital. Such services have been well established for children with a number of chronic conditions and although managing children with acute illnesses at home is not a new strategy, this model of care is increasingly considered an alternative to traditional in-patient hospitalisation. In addition to the financial benefits of transferring care to the patients' homes for health care providers and families, children and parents report a strong preference for such models of care.

Home oxygen therapy is considered an appropriate and relatively safe option for children with chronic respiratory problems such as chronic lung disease of prematurity, but the use of home oxygen therapy for children with acute respiratory problems is limited. With the recent establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to determine the safety, parental satisfaction and economic advantage of home oxygen therapy for children with acute bronchiolitis compared with traditional inpatient hospitalization.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

44

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

    • Western Australia
      • Perth, Western Australia, Australien, 6001
        • Princess Margaret Hospital for Children

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

3 måneder til 2 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 3 - 24 months of age (corrected gestation)
  2. Clinical diagnosis of acute bronchiolitis
  3. Adequate feeding (>50% normal) & hydration
  4. O2 saturation >92% on <1litre/minute nasal cannula oxygen.
  5. Observed and clinically stable for at least 24 hours in hospital
  6. Pass modified "safety in air test "
  7. Caregivers must be counseled about risk of smoking around a child receiving oxygen supplementation
  8. Caregivers must be adequately educated about home oxygen
  9. HiTH nurses able to visit at home at least twice daily, in addition to daily phone call
  10. Paediatrician agrees that child is eligible for recruitment in study

Exclusion Criteria:

  1. Pre-existing cardiac, pulmonary (including chronic lung disease of infancy, cystic fibrosis and congenital or acquired airway anomalies), and neuromuscular disorders
  2. History of apnea
  3. Prematurity <34 weeks gestation

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Children discharged home with oxygen
Administer oxygen at home or in hospital
Andre navne:
  • Home oxygen
  • Hospital oxygen
Ingen indgriben: 2
Children remain in hospital for oxygen therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Readmission to hospital
Tidsramme: Within 7 days of discharge
Within 7 days of discharge

Sekundære resultatmål

Resultatmål
Tidsramme
Number of days in hospital
Tidsramme: days
days
parent satisfaction
Tidsramme: discharge
discharge

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Andrew C Martin, FRACP, Princess Margaret Hospital for Children

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

1. august 2007

Primær færdiggørelse (Faktiske)

1. december 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

8. maj 2008

Først indsendt, der opfyldte QC-kriterier

12. maj 2008

Først opslået (Skøn)

13. maj 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. maj 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2008

Sidst verificeret

1. maj 2008

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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