Condition category
Neonatal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
27/01/2014
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 M K Lal

ORCID ID

Contact details

South Tees Hospital Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 282724
Mithilesh.lal@stees.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0227165397

Study information

Scientific title

Acronym

Study hypothesis

Variability in arterial PsO2 and PaCO2 as measured continuously by multiparameter arterial sensor (NeotrendR) in babies on different modes of mechanical ventilation.

Ethics approval

Not provided at time of registration

Study design

Single centre randomised crossover clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Neonatal Diseases

Intervention

Single-centre randomised crossover clinical trial.

Updated 27/01/2014: This trial was stopped because the manufacturers of the Neotrend/Paratrend device used for continuous blood gas monitoring went out of business and the product was no longer available.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Coefficient of variation in blood gases (PaO2 and PaC02) while receiving mechanical ventilation.

Secondary outcome measures

Incidental physiological data that are routinely collected in babies requiring intensive care, such as core temperature, arterial PH.

Overall trial start date

01/06/2005

Overall trial end date

31/12/2006

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

Preterm newborn infants < 34 weeks gestation, requiring mechanical ventilation for respiratory failure.

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

10

Participant exclusion criteria

All babies not receiving mechanical ventilation for respiratory failure.

Recruitment start date

01/06/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Tees Hospital Trust
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Tees Hospitals NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The James Cook University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes