Rickets Device - Feasibility Study

Rickets Clinical Trial

Official title:

Rachitis Device Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03105557
• Other study ID #: NL55778.091.15
• Status: Recruiting
• Start date: January 27, 2020
• Est. completion date: March 2024

Study information

• Verified date: February 2023
• Source: Capturin Distribution B.V.
• Contact: Petra Van Setten
• Phone: +31 (0)24 361 1111
• Email: petra.vansetten[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Rickets

Intervention

Device:
• Urinary collecting device
Urinary collecting device

Locations

Country	Name	City	State
Netherlands	Petra Van Setten	Arnhem	Gelderland

Sponsors (8)

Lead Sponsor	Collaborator
Capturin Distribution B.V.	Fonds NutsOhra, FrieslandCampina, Hertog Hendrik BV, Radboud University Medical Center, Rijnstate Hospital, Scint B.V., University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

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