Condition category
Respiratory
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
08/05/2013
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 Tom Hilliard

ORCID ID

Contact details

C/O Research and Effectiveness Department
Level 1
Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
BS2 8HW
United Kingdom
+44 0117 928 3473

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264191693

Study information

Scientific title

Acronym

Study hypothesis

We 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

Not provided at time of registration

Study design

Randomised open pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Respiratory: Severe acute bronchiolitis

Intervention

Randomised 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 type

Drug

Phase

Not Specified

Drug names

Vapotherm®

Primary outcome measures

Oxygen saturation (SpO2) 8 hours post randomisation to either Vapotherm or continuing conventional therapy.

Secondary outcome measures

1. 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 trial start date

15/01/2007

Overall trial end date

15/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects 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

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

32 infants

Participant exclusion criteria

1. 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

Recruitment start date

15/01/2007

Recruitment end date

15/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

United Bristol Healthcare NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22100741

Publication citations

  1. Results

    Hilliard TN, Archer N, Laura H, Heraghty J, Cottis H, Mills K, Ball S, Davis P, Pilot study of vapotherm oxygen delivery in moderately severe bronchiolitis., Arch. Dis. Child., 2012, 97, 2, 182-183, doi: 10.1136/archdischild-2011-301151.

Additional files

Editorial Notes