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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09187060

Enrollment

Registered

2007-09-28

Start date

2007-01-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory: Severe acute bronchiolitis Respiratory Severe acute bronchiolitis

Interventions

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 t

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026