Research with human participants

Overview of medical research in the Netherlands

Specturi Device - Feasibility study

Published:
Last updated:

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

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Bone, calcium, magnesium and phosphorus metabolism disorders
Study type
Observational non invasive

ID

NL-OMON54632

Source

ToetsingOnline

Brief title

Specturi feasibility study

Condition

  • Bone, calcium, magnesium and phosphorus metabolism disorders

Synonym

English disease, Rickets

Research involving

Human

Sponsors and support

Primary sponsor :
Capturin Distributie BV
Source(s) of monetary or material Support :
Fonds Nuts OHRA;Friesland Campina (tegenwoordig Hero Kindervoeding;xx);TKI PPP Allowance HH,Hertog Hendrik BV,Scint B.V.

Intervention

Keyword :
collecting device, Prematurely born newborns, Rickets, urine

Outcome measures

Primary outcome

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

parents

Secondary outcome

Skin reactions and skin irritability

Background summary

On a daily basis many (prematurely born) newborn a 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

Study objective

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. Every subject has a maximum of 3 tests.

Study burden and risks

This study involves a negligible amount of risk to a very vulnerable group of
test subjects, being neonates admitted to the neonatology unit of the
department of pediatrics of the Rijnstate hospital.

Public
Capturin Distributie BV

President Kennedylaan 100
Velp 6883 AZ
NL
Scientific
Capturin Distributie BV

President Kennedylaan 100
Velp 6883 AZ
NL

Listed location countries

Netherlands

Age

Newborns
Premature newborns (<37 weeks pregnancy)

Inclusion criteria

Neonates admitted to the neonatology unit of the Maternity care department of
Rijnstate Hospital and Radboud Hospital Nijmegen
Medical indication for urine testing using a urine collection device
Informed consent from parents

Exclusion criteria

No informed consent
Defective skin in genital region
Three previous test in the same subject

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
10
Type :
Actual

Medical products/devices used

Generic name :
Rachitis Collector Pad Device
Registration
:
No

Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
ClinicalTrials.gov NCT03105557
CCMO NL55778.091.15