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
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 design | Randomised open pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/01/2007 |
| Completion date | 15/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 32 infants |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
