Rickets Device - Feasibility Study

Recruiting

• Conditions: Rickets

• Registration Number: NCT03105557
• Lead Sponsor: Capturin Distribution B.V.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-10
• Study Start: 2020-01-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27
• Primary Completion: 2023-12
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Petra Van Setten; 🇳🇱 Arnhem, Gelderland, Netherlands