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
Protocol serial number	N0264191693
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	United Bristol Healthcare NHS Trust, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised open pilot study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Vapotherm®
Primary outcome measure(s)	Oxygen saturation (SpO2) 8 hours post randomisation to either Vapotherm or continuing conventional therapy.
Key secondary outcome measure(s)	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
Completion date	15/05/2007

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	32
Key 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
Key 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
Date of first enrolment	15/01/2007
Date of final enrolment	15/05/2007

C/O Research and Effectiveness Department

Bristol
BS2 8HW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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