A Pilot Study of Continuous Negative Pressure (CNEP) In Bronchiolitis
| ISRCTN | ISRCTN53796751 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53796751 |
| Protocol serial number | N/A |
| Sponsor | University Hospital of North Staffordshire (UK) |
| Funder | North Staffordshire and Royal Berkshire Hospitals |
- Submission date
- 05/03/2004
- Registration date
- 05/03/2004
- Last edited
- 09/08/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Martin Samuels
Scientific
Scientific
Academic Department of Paediatrics, University Hospital of North Staffordshire
Stoke on Trent
ST4 6QG
United Kingdom
| Phone | +44 (0)1782 552832 |
|---|---|
| samuels@doctors.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A Pilot Study of Continuous Negative Pressure (CNEP) In Bronchiolitis |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Bronchiolitis |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target sample size at registration | 42 |
| Key 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%. |
| Key exclusion criteria | Infants with bronchopulmonary dysplasia (BPD), congenital cardiac, pulmonary or neuromuscular diseases or signs of upper airway obstruction were excluded. |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Department of Paediatrics, University Hospital of North Staffordshire
Stoke on Trent
ST4 6QG
United Kingdom
ST4 6QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/08/2021: Internal review.
14/09/2017: The trial was completed early due to problems with equipoise in 1992. The results were published as an abstract only.
