Collection of urine in neonates and non-toilet trained infants Collection of urine in neonates and small infants
Conditions
Interventions
Investigation product name: Specturi Urine Collection DeviceThe Specturi urine collection device is developed to enable easier and quicker urine collection in non-toilet trained infants in a comfortab
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in the tests with the Specturi urine collection device, a subject should meet all of the following criteria:1. Urine collection with the Specturi urine collection deviceFemale infants between 1,300 and 10,000 gram who are admitted to the clinical and outpatient setting of the pediatrics and maternity departments at the study sites.Female infants that are stable according to the attending doctor and/or nurse and are able to participate in the study/to collect urine from.Informed consent from parents/guardian(s) as described in the informed consent procedure.2. Urine collection with both gauzes and the Specturi urine collection deviceFemale infants between 1,300 and 10,000 gram who are admitted to the clinical and outpatient setting of the pediatrics and maternity departments at Radboudumc Nijmegen.Female infants that are stable according to the attending doctor and/or nurse and are able to participate in the study/to collect urine from, including neonates at the maternity department.Optional: Female infants with a medical indication for the collection of urine with nonwoven cotton gauzes for any type of measurement or diagnostic test.Informed consent from parents/guardian(s) as described in the informed consent procedure.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:Defective skin in the genital region.Anatomical abnormalities that hinder the separation of urine and feces when using the Specturi urine collection device.Urine currently being collected by use of a catheter.Three previous urine collections in the same subject within this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The questionnaire filled out by the responsible nurses about the Specturi urine collection device consists about questions about efficiency of the urine collection, comfort and quality of life of the infant during urine collection, skin reaction as results of urine collection, and experience of urine collection. | — |
Secondary
| Measure | Time frame |
|---|---|
| The questionnaire filled out by the pediatric nurses about the current standard of care consists about questions about efficiency of the urine collection, comfort and quality of life of the infant during urine collection, skin reaction as results of urine collection, and experience of urine collection.In a selected group of urine collections, the total time needed as well as the medical staff time per urine collection method is measured.A trial-based cost-effectiveness analysis will be conducted. In this analysis, the impact of the Specturi device in comparison to the non-woven cotton gauzes and the urine collection bags in terms of healthcare resource use and accompanying costs will be evaluated from a hospital perspective over a time horizon of 3 days.The concentrations of sodium, potassium, chloride, calcium, phosphate, magnesium, glucose, creatinine, total protein, urea nitrogen, and nitrite as well as osmolality are measured and compared in the urine collected with non-woven cotton gauzes and the Specturi urine collection device. | — |
Countries
Netherlands
Contacts
Public Contact- Pediatric Research Unit Radboudumc
Radboud Universitair Medisch Centrum
Outcome results
None listed