A pilot randomised controlled study of oxygen delivery via Vapotherm® in infants with severe acute bronchiolitis

ISRCTN ISRCTN09187060
DOI https://doi.org/10.1186/ISRCTN09187060
Secondary identifying numbers N0264191693
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
08/05/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tom Hilliard
Scientific

C/O Research and Effectiveness Department
Level 1, Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
BS2 8HW
United Kingdom

Phone +44 0117 928 3473

Study information

Study designRandomised open pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesWe wish to study the safety and efficacy of the Vapotherm oxygen delivery device in infants with severe acute bronchiolitis in an initial pilot trial.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRespiratory: Severe acute bronchiolitis
InterventionRandomised open pilot study of oxygen delivery via Vapotherm compared with conventional therapy (optimum oxygen delivery via a headbox and appropriate intravenous fluids. Parents have up to 6 hours to decide whether to take part.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Vapotherm®
Primary outcome measureOxygen saturation (SpO2) 8 hours post randomisation to either Vapotherm or continuing conventional therapy.
Secondary outcome measures1. SpO2, heart rate, respiratory rate, FiO2 (oxygen concentration), blood pressure and combined bronchiolitis
2. Severity score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours after point of randomisation
3. Length of stay in hospital; length of time receiving oxygen therapy after randomisation; length of time before enteral feeds re-started after randomisation
4. Proportion of infants in each group that require further respiratory support, with either CPAP or intubation and mechanical ventilation
Overall study start date15/01/2007
Completion date15/05/2007

Eligibility

Participant type(s)Patient
Age groupNeonate
SexNot Specified
Target number of participants32 infants
Key inclusion criteriaSubjects will be infants less than 12 months of age admitted to hospital with a clinical diagnosis of
1. Bronchiolitis (clinical picture of cough, tachypnoea, chest retraction and crackles on auscultation) and
2. Features of severe disease:
2.1 Head−box oxygen requirement greater than 50% to maintain SpO2 at least 92%
2.2 Feeds have been discontinued, and intravenous fluid started
2.3 Moderate to severe tachypnoea and increased work of breathing
2.4 Triggering of the Paediatric Early Warning Tool
Key exclusion criteria1. Congenital cyanotic heart disease
2. Repeated severe apnoeas
3. Requirement for resuscitation with bag-mask ventilation
4. Severe hypercapnia (increased carbon dioxide) with acidosis on blood gas analysis of pH less than 7.2
5. Parental refusal or inability to give consent
Date of first enrolment15/01/2007
Date of final enrolment15/05/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

United Bristol Healthcare NHS Trust

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2012 Yes No