Low dose chemoprophylaxis (LDCP) and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and clean intermittent catheterisation (CIC)

ISRCTN	ISRCTN56278131
DOI	https://doi.org/10.1186/ISRCTN56278131
Secondary identifying numbers	NTR164

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs P Winkler-Seinstra
Scientific

University Medical Centre Utrecht
Wilhelmina Kinderziekenhuis
Department of Paediatrics, KE04.133.1
PO Box 85090
Utrecht
3508 AB
Netherlands

Phone	+31 (0)30 250 4001
Email	p.winkler@umcutrecht.nl

Study design	Multicentre randomised active-controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Low dose chemoprophylaxis (LDCP) and reduction of pyelonephritic episodes and significant bacteriuria in children with meningomyelocele and clean intermittent catheterisation (CIC)
Study acronym	SPIN UTI study
Study objectives	In meningomyelocele (MMC)-children treated with clean intermittent catheterisation (CIC), the incidences of significant bacteriuria and pyelonephritic episodes are only slightly smaller in the group of subjects treated with low dose chemoprophylaxis (LDCP) compared to the group without LDCP.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Meningomyelocele (MMC)
Intervention	The entire group with MMC and CIC is allocated randomly continuing LDCP or stopping LDCP.
Intervention type	Other
Primary outcome measure	1. Number of urinary tract infections 2. Number of pyelonephritic episodes
Secondary outcome measures	Changes in antibiotic resistance patterns in the cultured uropathogens
Overall study start date	21/02/2005
Completion date	01/05/2008

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	170
Key inclusion criteria	1. Neuropathic bladder-sphincter dysfunction 2. CIC and use of LDCP for at least 6 months 3. Good possibilities for communication 4. Written informed consent
Key exclusion criteria	1. Urinary tract infection (UTI) or - pyelonephritis at inclusion 2. Fever of unknown origin (e causa ignota [ECI]) 3. Other neurologic diseases 4. Other diseases like IDDM that can cause UTI
Date of first enrolment	21/02/2005
Date of final enrolment	01/05/2008

University Medical Centre Utrecht

Utrecht
3508 AB
Netherlands

University Medical Centre Utrecht (UMCU) (Netherlands)
University/education

PO Box 85500
Utrecht
3508 GA
Netherlands

Website	http://www.umcutrecht.nl/zorg/
"ROR"	https://ror.org/04pp8hn57

Research organisation

Wilhelmina Research Fund (Netherlands)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No
Results article	results	12/01/2017		Yes	No

16/01/2017: Publication reference added.