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Rickets Device - Feasibility Study

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ClinicalTrials.gov Identifier: NCT03105557
Recruitment Status : Not yet recruiting
First Posted : April 10, 2017
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
Fonds NutsOhra
FrieslandCampina
Rijnstate Hospital
Scint B.V.
Hertog Hendrik BV
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Rickets Device: Urinary collecting device

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rachitis Device Study
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Urinary collecting device
    Urinary collecting device
    Other Name: Capturin


Primary Outcome Measures :
  1. Questionnaire based clinical feasibility of the urine collection device, indicated by staff and parents [ Time Frame: 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 :
  1. Skin reactions [ Time Frame: 1 week ]
    Number of times skin reactions occurs, reported by the responsible nurse

  2. Skin irritability [ Time Frame: 1 week ]
    Number of times skin irritability occurs, reported by the responsible nurse



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will consist of prematurely born neonates who are admitted to the neonatology unit. And for which the attending physician has an indication to screen for rickets using calcium,phosphate and creatinine level measurement in urine.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105557


Contacts
Contact: Petra van Setten +31(0)880058888 pvansetten@rijnstate.nl
Contact: Bianca Baten +31(0)880056671 bbaten@rijnstate.nl

Locations
Netherlands
Rijnstate hospital Not yet recruiting
Arnhem, Gelderland, Netherlands, 6800 TA
Contact: Petra van Setten    +31(0)880058888    pvansetten@rijnstate.nl   
Contact: Bianca Baten    +31(0)880056671    bbaten@rijnstate.nl   
Sponsors and Collaborators
Capturin Distribution B.V.
Fonds NutsOhra
FrieslandCampina
Rijnstate Hospital
Scint B.V.
Hertog Hendrik BV

Responsible Party: Capturin Distribution B.V.
ClinicalTrials.gov Identifier: NCT03105557     History of Changes
Other Study ID Numbers: NL55778.091.15
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Capturin Distribution B.V.:
Prematurely born newborns
Urine
Collecting device

Additional relevant MeSH terms:
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders