Optimising arterial carbon dioxide during initial stabilisation in ventilated newborn infants: a randomised controlled trial
| ISRCTN | ISRCTN67254766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67254766 |
| Protocol serial number | N0544093462 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's Hospital NHS Foundation Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 09/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jagjit S Ahluwalia
Scientific
Scientific
Box No 226
Neonatal Intensive Care Unit
The Rosie Hospital
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 367417 |
|---|---|
| jag.ahluwalia@addenbrookes.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Optimising carbon dioxide in ventilated newborn infants. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 40 infants showing a 50% difference in the incidence of out of range in the first hour of life |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2000 |
| Date of final enrolment | 30/04/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box No 226
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2007 | Yes | No |
