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ISRCTN
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ISRCTN53796751
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ClinicalTrials.gov identifier
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Public title
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A Pilot Study of Continuous Negative Pressure (CNEP) In Bronchiolitis
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Bronchiolitis
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Participants - inclusion criteria
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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%.
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Participants - exclusion criteria
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Infants with bronchopulmonary dysplasia (BPD), congenital cardiac, pulmonary or neuromuscular diseases or signs of upper airway obstruction were excluded.
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Anticipated start date
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01/01/2004
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Anticipated end date
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31/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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42
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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North Staffordshire and Royal Berkshire Hospitals
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Trial website
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Publications
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Contact name
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Dr
Martin
Samuels
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Address
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Academic Department of Paediatrics, University Hospital of North Staffordshire
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City/town
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Stoke on Trent
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Zip/Postcode
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ST4 6QG
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Country
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United Kingdom
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Tel
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+44 (0)1782 552832
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Fax
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+44 (0)1782 713946
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Email
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samuels@doctors.org.uk
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Sponsor
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University Hospital of North Staffordshire (UK)
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Address
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Newcastle Road
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City/town
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Stoke on Trent
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Zip/Postcode
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ST4 6QG
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Country
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United Kingdom
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Tel
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+44 (0)1782 552832
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Fax
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+44 (0)1782 713946
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Email
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info@uhns.nhs.uk
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Sponsor website:
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http://www.uhns.nhs.uk
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Date applied
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05/03/2004
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Last edited
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19/09/2007
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Date ISRCTN assigned
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05/03/2004
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