Condition category
Neonatal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/10/2015
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

Dr Steve Byrne

ORCID ID

Contact details

Neonatology
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0217106473

Study information

Scientific title

Volume controlled ventilation for treatment of respiratory failure in preterm infants

Acronym

Study hypothesis

Is there any significant difference in length of ventilation in babies randomised to receive volume controlled or time-cycled pressure limited ventilation?

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neonatal Diseases: Respiratory

Intervention

Randomised controlled trial.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

length of ventilation required

Secondary outcome measures

1. incidence of air leak
2. intraventricular hemorrhage (IVH)
3. necrotising enterocolitis (NEC)

Overall trial start date

01/03/2002

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Babies of <500-1500 g requiring ventilation.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/03/2002

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neonatology
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Salford Royal Hospitals NHS Foundation 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

Publication citations

Additional files

Editorial Notes