Condition category
Respiratory
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
26/04/2011
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 Sunil Sinha

ORCID ID

Contact details

Women & Children Division
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 854874
s.k.sinha@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0227097989

Study information

Scientific title

Acronym

Study hypothesis

To assess the efficacy and safety of these newer modes of artificial ventilation, and assess their superiority over conventional ventilation in terms of mortality, analysis of cost of treatment, and short and long term respiratory outcome.

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

Respiratory failure

Intervention

Randomised controlled trial of different modes of ventilation. Patients were randomised to different modes of ventilation, or the conventional ventilation methods.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Duration of ventilation and weaning

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/1999

Overall trial end date

31/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Babies less than 1500 g with respiratory distress syndrome (RDS) requiring ventilation

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1999

Recruitment end date

31/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Women & Children Division
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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 (UK)

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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16939738
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17394932
3. 2008 results in http://iospress.metapress.com/content/4t78246566811154/
4. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18676412
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19321507

Publication citations

  1. Results

    Singh J, Sinha SK, Clarke P, Byrne S, Donn SM, Mechanical ventilation of very low birth weight infants: is volume or pressure a better target variable?, J. Pediatr., 2006, 149, 3, 308-313, doi: 10.1016/j.jpeds.2006.01.044.

  2. Results

    Singh J, Sinha SK, Donn SM, Volume-targeted ventilation of newborns., Clin Perinatol, 2007, 34, 1, 93-105, vii, doi: 10.1016/j.clp.2006.12.007.

  3. Results

    Gupta S, Sinha SK, Donn SM, The effect of two levels of pressure support ventilation on tidal volume delivery and minute ventilation in preterm infants., Arch. Dis. Child. Fetal Neonatal Ed., 2009, 94, 2, F80-3, doi: 10.1136/adc.2007.123679.

  4. Results

    Singh J, Sinha SK, Alsop E, Gupta S, Mishra A, Donn SM, Long term follow-up of very low birthweight infants from a neonatal volume versus pressure mechanical ventilation trial., Arch. Dis. Child. Fetal Neonatal Ed., 2009, 94, 5, F360-2, doi: 10.1136/adc.2008.150938.

Additional files

Editorial Notes