Screening the Newborn for Familial Ureteric Reflux
| ISRCTN | ISRCTN88374184 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88374184 |
| Secondary identifying numbers | 93020001 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 21/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Scott
Scientific
Scientific
School of Population and Health Sciences
University of Newcastle upon Tyne
Newcastle upon Tyne
NE2 4HH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 06/01/1993 |
| Completion date | 31/05/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Population and Health Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/08/1997 | Yes | No |
