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OpenTrials
Completed

NCT Number: NCT03105557

Specturi Device - Feasibility Study

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.

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Key information

Conditions

Rickets Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Deficiency Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Sex eligibility

Female

Study type

Observational

Primary location

Petra Van Setten

Arnhem, Gelderland, 6800 TA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urinary collecting device

Device

Urinary collecting device

Other names: Capturin

Primary outcomes

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

    Time frame: 1 day

    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

Secondary outcomes

  1. Skin reactions

    Time frame: 1 week

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

  2. Skin irritability

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Capturin Distribution B.V.

Industry

Collaborators

  • Fonds NutsOhra
  • FrieslandCampina
  • Hertog Hendrik BV
  • Radboud University Medical Center
  • Rijnstate Hospital
  • Scint B.V.
  • University of Twente

Registry information

Official study title

Specturi Device Study

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2017
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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