Rickets Device - Feasibility Study

NCT ID: NCT03105557

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-27

Study Completion Date

2024-03-31

Brief Summary

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On a daily basis many (prematurely born) newborn are subjected to different urine collecting techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are looking for a better and less invasive manner to collect urine in these vulnerable patients. We hypothesise that the urine collecting device as presented in this protocol is less invasive and has good functional abilities to collect urine in these newborns

Objective of the study:

Clinical feasibility of the urine collection device, indicated by staff and parents.

Study design:

The study will be an open label, clinical feasibility study, of the urine collection device. During a period of 6 months, 30 feasibility tests will be performed.

Study population:

Prematurely born newborns, admitted to the neonatology unit of the department of pediatrics at Rijnstate Hospital Arnhem.

Detailed Description

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Conditions

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Rickets

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Urinary collecting device

Urinary collecting device

Intervention Type DEVICE

Other Intervention Names

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Capturin

Eligibility Criteria

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Inclusion Criteria

* Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels Informed consent from parents

Exclusion Criteria

* No informed consent
* Defective skin in genital region
* Three previous tests in the same subject
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fonds NutsOhra

OTHER

Sponsor Role collaborator

FrieslandCampina

INDUSTRY

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Scint B.V.

UNKNOWN

Sponsor Role collaborator

Hertog Hendrik BV

UNKNOWN

Sponsor Role collaborator

University of Twente

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Capturin Distribution B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Petra Van Setten

Arnhem, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Petra Van Setten

Role: CONTACT

+31 (0)24 361 1111

Bianca Baten

Role: CONTACT

+31(0)880056671

Facility Contacts

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Petra Van Setten

Role: primary

+31(0)880058888

Bianca Baten

Role: backup

+31(0)880056671

Other Identifiers

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NL55778.091.15

Identifier Type: -

Identifier Source: org_study_id

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