Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Khalid N Haque

ORCID ID

Contact details

Epsom and St Helier NHS Trust
Department of Neonatology
Queen Mary's Hospital for Children
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
+44 (0)20 8296 2930

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes