Urinary Neurotrophin Levels in Healthy Children
Age and Daytime Variations in Urinary Neurotrophin Levels in Healthy Children Without Lower Urinary Tract Symptoms
1 other identifier
observational
150
0 countries
N/A
Brief Summary
The aim of this study is to analyse urinary neurotrophin levels in healthy children. Urine samples will be collected at 3 different times of day (morning, noon, and evening) at urge sensation from all age groups of children who gained bladder control, i.e. from 3-18 years of age. Urinary levels of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinine will be analysed. Age and daytime related variations will be reported for both boys and girls. These results will contribute to understanding the role of neurotrophins in the physiology of lower urinary tract and pathophysiology of idiopathic and secondary hyperactive bladder in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 8, 2016
March 1, 2016
5 months
March 10, 2015
March 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration of urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinin
We will collect urine samples from healthy children without lower urinary tract symptoms and analyse urine concentrations of neurotrophins (NGF and BDNF) normalised to urinary creatinin in order to report its normal age- and daytime-related variations.
Collection of urine samples and analysis will take approximately 6 months.
Study Arms (1)
Healthy children
Healthy children without lower urinary tract diseases, history of urinary tract infection, chronic diseases, anomalies of urinary or genital tract, and remarkable clinical examination.
Eligibility Criteria
We will include a group of healthy children recruited from a primary care clinic.
You may qualify if:
- years of age
- a unremarkable clinical examination
- a normal voiding pattern
- a minimum of 3 micturitions per day
- informed oral and written consent from the child and both parents/legal guardian
You may not qualify if:
- history of urinary tract infection
- diseases of central or peripheral nerve system
- anomalies of lumbosacral region
- chronic diseases
- operative procedures or anomalies of urinary or genital tract
- lower urinary tract symptoms
- constipation
- hypercalcuria
- urolithiasis, depression, eating disorders or cardio-metabolic diseases
- prior use of anticholinergic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Urine ultrafiltrate
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Slaven Abdovic, MD, PhD
Children's Hospital Zagreb
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 17, 2015
Study Start
March 1, 2016
Primary Completion
August 1, 2016
Study Completion
December 1, 2016
Last Updated
March 8, 2016
Record last verified: 2016-03