Effect of Continuous Intra Arterial Weak Bicarbonate Infusion on the Use of Fluid and Bicarbonate Boluses to Correct Metabolic Acidosis in Babies Weighing Less than 1000 g and Who are Less than 32 Weeks Gestation at Birth
| ISRCTN | ISRCTN22535466 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22535466 |
| Secondary identifying numbers | N0051113384 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 15/05/2012
- 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 Fiona Weir
Scientific
Scientific
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | A continuous infusion of bicarbonate in very low birth weight infants over the first four days of life will reduce the need for bolus bicarbonate or fluid infusions to correct academia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases: Metabolic acidosis |
| Intervention | Randomised controlled trial |
| Intervention type | Other |
| Primary outcome measure | Continuous weak alkali infusion may prevent acidosis from occurring and reduce the need for boluses of fluid or bicarbonate. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/10/2001 |
| Completion date | 30/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Babies 32 weeks gestational age weighing <1000 g |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 30/10/2001 |
| Date of final enrolment | 30/08/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Brighton and Sussex University Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 18/04/2005 | Yes | No |
