Rickets Device - Feasibility Study

Capturin Distribution

Status: Enrolling

Conditions: Rickets

Treatments: Device: Urinary collecting device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03105557

NL55778.091.15

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Volunteers: No 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