A study of serially measured cystatin C and iohexol clearance for the determination of glomerular filtration rate (GFR) in pre-term neonates
| ISRCTN | ISRCTN21536778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21536778 |
| Secondary identifying numbers | N0112112982 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 05/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Khalid N Haque
Scientific
Scientific
Epsom and St Helier NHS Trust
Department of Neonatology
Queen Mary's Hospital for Children
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
| Phone | +44 (0)20 8296 2930 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study objectives | 1. To determine whether serum cystatin C provides a more accurate estimate of glomerular filtration rate (GFR) than creatinine in a pre-term neonatal population 2. To determine whether serum cystatin C levels differ significantly between asphyxiated and representative non-asphyxiated neonates |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Renal injury in preterm neonates |
| Intervention | Measures to be taken for glomerular filtration rate: 1. Serum cystatin C 2. Creatinine |
| Intervention type | Other |
| Primary outcome measure | Validated test for renal injury in neonates |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 07/12/2001 |
| Completion date | 07/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Pre-term infants from the Neonatal Unit at St Helier Hospital, less than 37 weeks gestation |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 07/12/2001 |
| Date of final enrolment | 07/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
SM5 1AA
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
Government
Epsom and St Helier 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 |
