Condition category
Respiratory
Date applied
05/03/2004
Date assigned
05/03/2004
Last edited
17/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Samuels

ORCID ID

Contact details

Academic Department of Paediatrics
University Hospital of North Staffordshire
Stoke on Trent
ST4 6QG
United Kingdom
+44 (0)1782 552832
samuels@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

31/12/2004

Reason abandoned

Objectives no longer viable

Eligibility

Participant 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%.

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

42

Participant exclusion criteria

Infants with bronchopulmonary dysplasia (BPD), congenital cardiac, pulmonary or neuromuscular diseases or signs of upper airway obstruction were excluded.

Recruitment start date

01/01/2004

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Paediatrics, University Hospital of North Staffordshire
Stoke on Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

University Hospital of North Staffordshire (UK)

Sponsor details

Newcastle Road
Stoke on Trent
ST4 6QG
United Kingdom
+44 (0)1782 552832
info@uhns.nhs.uk

Sponsor type

Government

Website

http://www.uhns.nhs.uk

Funders

Funder type

Government

Funder name

North Staffordshire and Royal Berkshire Hospitals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1994 Abstract in Hartmann H, Noyes JP, Wright T, Wheatley R, Spencer A, Boon A, Alexander J, Samuels MP, Southall DP. Continuous negative extrathoracic pressure ventilation in infants with bronchiolitis. Eur Respir J 1994;S18:379.

Publication citations

Additional files

Editorial Notes