Rickets Clinical Trial
Official title:
Rachitis Device Study
| NCT number | NCT03105557 |
| Other study ID # | NL55778.091.15 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 27, 2020 |
| Est. completion date | March 2024 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Petra Van Setten | Arnhem | Gelderland |
| 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 |
Netherlands,
| 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 |
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