Specturi Device - Feasibility Study

NCT03105557 | Completed

• 1 other identifier: NL55778.091.15
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prematurely born newborns; Urine; Collecting device

Outcome Measures

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

  1 day

Secondary Outcomes (2)

• Skin reactions

  1 week

• Skin irritability

  1 week

Interventions

Urinary collecting device DEVICE

Urinary collecting device

Also known as: Capturin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Scint B.V.: collaborator
• Hertog Hendrik BV: collaborator
• University of Twente: collaborator
• Radboud University Medical Center: collaborator
• Capturin Distribution B.V.: lead
• Fonds NutsOhra: collaborator
• FrieslandCampina: collaborator
• Rijnstate Hospital: collaborator

Study Sites (1)

Petra Van Setten

Arnhem, Gelderland, 6800 TA, Netherlands

Location

MeSH Terms

Conditions

Rickets

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: April 10, 2017
• Study Start: January 27, 2020
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

NL (1)