Urinary Neurotrophin Levels in Healthy Children

March 5, 2016 updated by: Children's Hospital Zagreb

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will include a group of healthy children recruited from a primary care clinic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinin
Time Frame: 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.
Collection of urine samples and analysis will take approximately 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Zagreb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 5, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pOAB-CHZ-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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