Condition category
Neonatal Diseases
Date applied
08/03/2004
Date assigned
09/03/2004
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Southall

ORCID ID

Contact details

Academic Department of Paediatrics
University Hospital of North Staffordshire
Stoke on Trent
ST4 6QG
United Kingdom
+44 (0)1782 552575
davids@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CNEP

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neonatal respiratory failure (respiratory distress syndrome)

Intervention

Patients were randomised at four hours of age to receive either standard neonatal intensive care, or standard care plus continuous negative extrathoracic pressure (CNEP, -4 to -6 cm H2O) applied within a purpose-designed neonatal incubator.

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

01/10/1989

Overall trial end date

01/11/1993

Reason abandoned

Eligibility

Participant inclusion criteria

The trial was undertaken in two neonatal intensive care units, Queen Charlotte's and Chelsea Hospital (QCCH) and North Staffordshire Maternity
Hospital (NSMH), between October 1989 and November 1993.
There were 244 patients: birth weight 1.53 ± 0.69 kg (mean ± SD), gestational age 30.4 ± 3.5 weeks, with respiratory failure.
Patients were considered for entry at 2 hours of age if they required
additional inspired oxygen or ventilation to maintain an arterial partial pressure of oxygen (PO2) of ≥8 kPa (60 mm Hg: conversion factor 7.5) or
an arterial partial pressure of carbon dioxide (PCO2) of <6.5 kPa at Queen Charlotte's and Chelsea Hospital (QCCH) or 8 kPa at North Staffordshire Maternity Hospital (NSMH). This latter difference was because the two participating units had different practices at the time the trial commenced.
Patients were randomised if, after a second assessment at 4 hours of age, they required ≥40% inspired oxygen or ventilation to maintain these blood gas measurements.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

244

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1989

Recruitment end date

01/11/1993

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Paediatrics
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 715444
info@uhns.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Horner & Wells (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Priory Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dunhill Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Moorgate Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Little Ones (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Queen Charlotte's and Chelsea Hospital (QCCH) (UK) - use of their premises

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

North Staffordshire Maternity Hospital (NSMH) (UK) - use of their premises

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

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=8951269

Publication citations

  1. Results

    Samuels MP, Raine J, Wright T, Alexander JA, Lockyer K, Spencer SA, Brookfield DS, Modi N, Harvey D, Bose C, Southall DP, Continuous negative extrathoracic pressure in neonatal respiratory failure., Pediatrics, 1996, 98, 6 Pt 1, 1154-1160.

Additional files

Editorial Notes