Condition category
Neonatal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/12/2009
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 John Scott

ORCID ID

Contact details

School of Population and Health Sciences
University of Newcastle upon Tyne
Newcastle upon Tyne
NE2 4HH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

93020001

Study information

Scientific title

Acronym

Study hypothesis

Ureteric reflux is an asymptomatic malfunction in the urinary tract: when complicated by urinary infection reflux nephropathy ensues; this causes end-stage renal failure in a significant number of young adults. To prevent reflux nephropathy, reflux must be detected before infection occurs. The peak incidence for infection is in early infancy, so reflux must be detected in the newborn. Reflux is a familial condition thought to have a sibling prevalence of 40%. A detailed enquiry to elicit the presence of reflux in members of a pregnant mothers family will enable an at risk population to be mustered antenatally. These babies will be subjected to cystography at birth. To determine whether chemoprophylaxis will prevent the onset of renal scarring, babies in whom reflux is detected will be randomised into two groups; one group will be given the therapy, the other will not. Assessment will take place at 3 years and 5 years.

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

Screening

Patient information sheet

Condition

Neonatal diseases; Other urological and genital disease

Intervention

Maintenance chemotherapy with trimethoprim 2 mg/kg daily

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

06/01/1993

Overall trial end date

31/05/1995

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant mothers with a familial ureteric reflux problem

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

06/01/1993

Recruitment end date

31/05/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Population and Health Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (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

1997 results in http://www.ncbi.nlm.nih.gov/pubmed/9259653

Publication citations

  1. Results

    Scott JE, Swallow V, Coulthard MG, Lambert HJ, Lee RE, Screening of newborn babies for familial ureteric reflux., Lancet, 1997, 350, 9075, 396-400.

Additional files

Editorial Notes