Specturi Device - Feasibility Study

Specturi Device Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03105557

Enrollment

Registered

2017-04-10

Start date

2020-01-27

Completion date

2025-02-05

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rickets

Keywords

Prematurely born newborns, Urine, Collecting device

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.

Interventions

DEVICEUrinary collecting device

Urinary collecting device

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents	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

Measure	Time frame	Description
Skin reactions	1 week	Number of times skin reactions occurs, reported by the responsible nurse
Skin irritability	1 week	Number of times skin irritability occurs, reported by the responsible nurse

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026