Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0544093462
Study information
Scientific title
Acronym
Study hypothesis
Optimising carbon dioxide in ventilated newborn infants.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study 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
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/06/2000
Overall study end date
30/04/2003
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Neonate
Sex
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
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2007 | Yes | No |