Screening the Newborn for Familial Ureteric Reflux

ISRCTN	ISRCTN88374184
DOI	https://doi.org/10.1186/ISRCTN88374184
Protocol serial number	93020001
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr John Scott
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal diseases; Other urological and genital disease
Intervention	Maintenance chemotherapy with trimethoprim 2 mg/kg daily
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/05/1995

Participant type(s)	Patient
Age group	Neonate
Sex	All
Key inclusion criteria	Pregnant mothers with a familial ureteric reflux problem
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	06/01/1993
Date of final enrolment	31/05/1995

School of Population and Health Sciences

Newcastle upon Tyne
NE2 4HH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/08/1997		Yes	No