| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN53796751 |
| Date ISRCTN assigned | 05/03/2004 |
| Local reference number(s) | N/A |
| Public title | A Pilot Study of Continuous Negative Pressure (CNEP) In Bronchiolitis |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Bronchiolitis |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Forty two infants admitted with bronchiolitis, who needed more than 40% oxygen therapy to maintain normal levels of arterial oxygen saturation. This was a pilot study. Forty two patients were enrolled between January 1991 and April 1992 in two paediatric hospitals in England (North Staffordshire Hospital and Royal Berkshire Hospital) if they fulfilled the following criteria:
1. Clinical diagnosis of bronchiolitis (irrespective of whether respiratory syncitial virus was isolated)
2. Age 1 year
3. Presence of respiratory failure with fractional inspired oxygen (FiO2) 0.4 to achieve an arterial oxygen saturation (SaO2) of 96-99%. |
| Participants - exclusion criteria | Infants with bronchopulmonary dysplasia (BPD), congenital cardiac, pulmonary or neuromuscular diseases or signs of upper airway obstruction were excluded. |
| Patient information material |
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| Anticipated start date | 01/01/2004 |
| Anticipated end date | 31/12/2004 |
| Status of trial | Completed |
| Target number of participants | 42 |
| Interventions | Infants were randomised to either standard treatment, or standard with CNEP.
Inspired oxygen requirement was measured with a calibrated oxygen analyser placed close to the infant's nose in a headbox, in which the oxygen flow was adjusted to maintain SaO2 96-99% at rest, measured with a Nellcor N-200 pulse oximeter.
When an infant fulfilled the entry criteria, written informed consent was obtained from parents and baseline data was collected.
Patients were then randomised to either conventional therapy or conventional therapy plus CNEP. The randomisation was performed using a stratification scheme to achieve a measure of balance in the treatment groups.
Conventional therapy in these hospitals included the use of additional inspired oxygen and bronchodilators. Infants were intubated and positive pressure ventilation (PPV) was initiated in the presence of respiratory acidosis with a pH below 7.25, hypercapnia, hypoxaemia in spite of additional inspired oxygen, recurrent apnoea and respiratory fatigue.
CNEP was applied using purpose built systems (Horner and Wells Ltd, Chelmsford, UK, and DHB Tools Ltd, Leamington Spa, UK).
Treatment was begun with -4 cmH2O of CNEP. If the FiO2 required to achieve normal SaO2 did not decrease within the next 30 min, CNEP was decreased to -6 cmH2O. Weaning from CNEP was attempted after a treatment period of at least 24 hours and usually in the presence of an FiO2<0.3.
Infants were fed by either nasogastric tube, or intravenously, according to the degree of respiratory distress.
Heart rate, respiratory rate and FiO2 were recorded hourly if the infants were at rest when they were treated with additional inspired oxygen. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | North Staffordshire and Royal Berkshire Hospitals |
| Sponsor name | University Hospital of North Staffordshire (UK) |
| Sponsor details | Newcastle Road
Stoke on Trent
United Kingdom
ST4 6QG |
| Sponsor telephone | +44 (0)1782 552832 |
| Sponsor fax | +44 (0)1782 713946 |
| Sponsor email | info@uhns.nhs.uk |
| Sponsor website | http://www.uhns.nhs.uk |
| Contact name | Dr Martin Samuels |
| Contact details | Academic Department of Paediatrics, University Hospital of North Staffordshire
Stoke on Trent
United Kingdom
ST4 6QG |
| Contact telephone | +44 (0)1782 552832 |
| Contact fax | +44 (0)1782 713946 |
| Contact email | samuels@doctors.org.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN53796751 |
| Date last extracted from ISRCTN register | 17/04/2008 |
