CClinicalTrials.gg
CompletedNCT03105557Updated Feb 27, 2026

Specturi Device - Feasibility Study

An observational study in Rickets, sponsored by Capturin Distribution B.V.. Completed at 1 site in Netherlands. Open to female participants. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Capturin Distribution B.V. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Rickets

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Keywords

  • Prematurely born newborns
  • Urine
  • Collecting device
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects will consist of prematurely born neonates who are admitted to the neonatology unit. And for which the attending physician has an indication to screen for rickets using calcium,phosphate and creatinine level measurement in urine.

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

Exclusion Criteria:

  • No informed consent
  • Defective skin in genital region
  • Three previous tests in the same subject
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Interventions

  • DeviceUrinary collecting device

    Urinary collecting device

    Also known as: Capturin

05

What researchers measure

Primary outcomes

  1. Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents

    With concern to feasibility we want to know whether this device is able: * easy to apply to the neonate * to only collect urine * to exclude stool admixture * easy to use by the nurses * comfortable for te neonates

    Time frame: 1 day

Secondary outcomes

  1. Skin reactions

    Number of times skin reactions occurs, reported by the responsible nurse

    Time frame: 1 week

  2. Skin irritability

    Number of times skin irritability occurs, reported by the responsible nurse

    Time frame: 1 week

06

Study locations

1 site
  • Petra Van Setten
    Arnhem, Gelderland 6800 TA, Netherlands
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03105557
Lead sponsor
Capturin Distribution B.V.
Collaborators
Fonds NutsOhra, FrieslandCampina, Rijnstate Hospital, Scint B.V., Hertog Hendrik BV, University of Twente, Radboud University Medical Center
Responsible party
Sponsor
First posted
Apr 10, 2017
Start date
Jan 27, 2020
Primary completion
Feb 5, 2025
Completion
Feb 5, 2025
Last update
Feb 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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