Specturi Device - Feasibility Study

NCT03105557 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-02-27

No results posted yet for this 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.

Conditions

  • Rickets

Interventions

DEVICE

Urinary collecting device

Urinary collecting device

Sponsors & Collaborators

  • Fonds NutsOhra

    collaborator OTHER
  • FrieslandCampina

    collaborator INDUSTRY
  • Rijnstate Hospital

    collaborator OTHER
  • Scint B.V.

    collaborator UNKNOWN
  • Hertog Hendrik BV

    collaborator UNKNOWN
  • University of Twente

    collaborator OTHER
  • Radboud University Medical Center

    collaborator OTHER
  • Capturin Distribution B.V.

    lead INDUSTRY

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-27
Primary Completion
2025-02-05
Completion
2025-02-05

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03105557 on ClinicalTrials.gov