Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0112112982
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Renal injury in preterm neonates
Intervention
Measures to be taken for glomerular filtration rate:
1. Serum cystatin C
2. Creatinine
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Validated test for renal injury in neonates
Secondary outcome measures
Not provided at time of registration
Overall trial start date
07/12/2001
Overall trial end date
07/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Pre-term infants from the Neonatal Unit at St Helier Hospital, less than 37 weeks gestation
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
07/12/2001
Recruitment end date
07/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Epsom and St Helier NHS Trust
Carshalton
SM5 1AA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Epsom and St Helier University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary