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 |
| Protocol serial number | N0051113384 |
| Sponsor | Department of Health |
| Funder | Brighton and Sussex University Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Continuous weak alkali infusion may prevent acidosis from occurring and reduce the need for boluses of fluid or bicarbonate. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
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 | 18/04/2005 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
