Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
23/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Carr

ORCID ID

Contact details

Paediatric department
2nd Floor
Fielden House
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
+44 (0)20 7377 7462
siobhan.carr@bartsandthelondon.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205134443

Study information

Scientific title

Acronym

Study hypothesis

This study aims to identify which treatment modality (CPAP [Continuous Positive Airways Pressure] or traditional supportive management) is more successful in infants with bronchiolitis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Respiratory: Bronchiolitis

Intervention

A pilot study. A randomised cross-over design will be used. Infants who have reached the inclusion criteria will be randomised to either 12 hours of CPAP or 12 hours of traditional supportive management. They will then cross over into the other arm, to act as their own controls, and receive further hours of the opposite treatment. After 24 hours their clinical management will be as of the team looking after the child.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Change in partial pressure of Carbon dioxide (pCO2)
2. Change in Fraction of inspired Oxygen (FiO2)
3. Change in heart rate
4. Change in respiratory rate

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2001

Overall trial end date

01/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Children less than one year of age with a clinical diagnosis of bronchiolitis.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

31

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/11/2001

Recruitment end date

01/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Paediatric department
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17344251

Publication citations

  1. Thia LP, McKenzie SA, Blyth TP, Minasian CC, Kozlowska WJ, Carr SB, Randomised controlled trial of nasal continuous positive airways pressure (CPAP) in bronchiolitis., Arch. Dis. Child., 2008, 93, 1, 45-47, doi: 10.1136/adc.2005.091231.

Additional files

Editorial Notes