NCT03263845

Brief Summary

Observational study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

August 24, 2017

Last Update Submit

August 24, 2017

Conditions

Urinary Tract Infections in Children

Outcome Measures

Primary Outcomes (1)

  • Evaluation of pain

    Score of the visual analog scale rated by the caregiver during the first performed gesture.

    Day 0

Secondary Outcomes (4)

  • Evaluation of pain

    Day 0

  • Evaluation of pain

    Day 0

  • The experience of the gesture by the parent and the caregiver

    Day 0

  • Time needed to collect urine

    Day 0

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.

You may qualify if:

  • Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35200, France

Location

Study Officials

  • Amelie Rickewaert

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

July 5, 2016

Primary Completion

January 13, 2017

Study Completion

January 13, 2017

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

FR(1)