Condition category
Neonatal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
09/10/2014
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 Jagjit S Ahluwalia

ORCID ID

Contact details

Box No 226
Neonatal Intensive Care Unit
The Rosie Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 367417
jag.ahluwalia@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544093462

Study information

Scientific title

Acronym

Study hypothesis

Optimising carbon dioxide in ventilated newborn infants.

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 Diseases: Artificial ventilation

Intervention

1. Synchronised Intermittent Postive Pressure Ventilation (SIPPV)
2. SIPPV plus Volume Guarantee

Infants requiring artificial ventilation will be entered in the trial following antenatal parental assent. Formal consent will be obtained within 24 h of birth. Study infants will be randomly assigned to either receive Synchronised Intermittent Positive Pressure Ventilation (SIPPV) or SIPPV plus Volume Guarantee (VG). The assigned mode of ventilation will continue until arterial access has been obtained and results of blood gas analysis are available. The infants will then continue on the clinician determined mode of ventilation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2000

Overall trial end date

30/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

40 infants showing a 50% difference in the incidence of out of range in the first hour of life

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2000

Recruitment end date

30/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 226
Cambridge
CB2 2QQ
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

Government

Funder name

Cambridge Consortium - Addenbrooke's Hospital 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

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/16815649

Publication citations

  1. Results

    Cheema IU, Sinha AK, Kempley ST, Ahluwalia JS, Impact of volume guarantee ventilation on arterial carbon dioxide tension in newborn infants: a randomised controlled trial., Early Hum. Dev., 2007, 83, 3, 183-189, doi: 10.1016/j.earlhumdev.2006.05.013.

Additional files

Editorial Notes