Randomised controlled trial of acetate in preterm neonates receiving parenteral nutrition
| ISRCTN | ISRCTN58031154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58031154 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 18/11/2010
- 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 Steven Ryan
Scientific
Scientific
Neonatal Unit
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
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 |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal diseases |
| Intervention | Standard parenteral nutrition vs novel formulation with replacement of any chloride dose >3 mmol/kg/day as acetate |
| 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 | 01/07/1995 |
| Completion date | 30/07/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | Added as of 23/05/2008: 30 |
| Key inclusion criteria | Preterm neonates under 32 weeks gestation were entered into the study if they were still receiving intravenous glucose/electrolyte solution on day 3, but not receiving enteral nutrition. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/1995 |
| Date of final enrolment | 30/07/1996 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Neonatal Unit
Liverpool
L8 7SS
United Kingdom
L8 7SS
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive North West (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 | 01/07/1997 | Yes | No |
