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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22100741
Publication citations
-
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.