Urinary Neurotrophin Levels in Healthy Children

Sponsor

Children's Hospital Zagreb (Other)

Overall Status

Unknown status

CT.gov ID

NCT02389270

Collaborator

(none)

150

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Age and Daytime Variations in Urinary Neurotrophin Levels in Healthy Children Without Lower Urinary Tract Symptoms

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Concentration of urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinin [Collection of urine samples and analysis will take approximately 6 months.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

3-18 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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Children's Hospital Zagreb

Investigators

Principal Investigator: Slaven Abdovic, MD, PhD, Children's Hospital Zagreb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital Zagreb

ClinicalTrials.gov Identifier:

NCT02389270

Other Study ID Numbers:

pOAB-CHZ-00

First Posted:

Mar 17, 2015

Last Update Posted:

Mar 8, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Children's Hospital Zagreb

Neurotrophins

Nerve Growth Factor

Brain-Derived Neurotrophic Factor

Urinary Biomarkers

Children

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Study Results

No Results Posted as of Mar 8, 2016