|- candidate number||15046|
|- NTR Number||NTR4039|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jun-2013|
|- Secondary IDs||1203-029 |
|- Public Title||Reducing skinbreaking procedures in newborns |
|- Scientific Title||Reducing the number of skin breaking procedures: a randomized controlled trial comparing two vascular imaging devices|
|- ACRONYM||PRIK project|
|- hypothesis||The percentage of successful PIV insertions at the first attempt in newborns will increase with the Veinviewer® and/or Astodia®, two vascular imaging devices|
|- Healt Condition(s) or Problem(s) studied||Infant-newborn, Insertion, Peripheral IV cannula (PIV) insertion |
|- Inclusion criteria||All consecutive newborns admitted to the NICU of the Erasmus MC-Sophia Children’s Hospital requiring a PIV in the first 2 weeks of life.|
|- Exclusion criteria||Newborns older than 2 weeks of age.|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2013|
|- planned closingdate||1-aug-2014|
|- Target number of participants||321|
|- Interventions||Patients will be randomized to one of three conditions during insertion of a peripheral infusion. The first time a newborn requires a peripheral intravenous cannula in the unit, randomisation will be performed to 1) with support of a device that helps to visualise the veins using infrared light (intervention A) or 2)with support of another device that visualises the veins using LED (intervention B) or without support using hands and eyes. In the control group PIV insertion will take place without any device. |
|- Primary outcome||The main study parameter is the percentage of procedures, which are successful in one attempt. |
|- Secondary outcome||The secondary study parameters will be the total number of punctures necessary for a PIV insertion and the duration of the insertion procedure. |
|- Timepoints||Data collection will take place until 321 patients are included|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Roland Rens, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Monique Dijk, van|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital, Department of Neonatology Intensive Care, Erasmus Medical Center, Sophia Children’s Hospital, Department of Pediatric Pulmonology|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Peripheral IV cannula (PIV) insertion is a difficult and painful but inevitable procedure in hospitalized patients. The procedure is especially in neonates hampered by difficult visualization of blood vessels. Unfortunately, multiple puncture attempts are frequently necessary. To improve vessel puncturing in neonates, we compared three insertion methods.
Objective: The objective of this study is to evaluate the effectiveness of two vascular imaging devices in peripheral IV cannula insertion in neonates.|
Study design: The study is a randomized controlled trial.
Study population: The study population will consist of 321 neonates admitted to the neonatal ward of the Erasmus MC-Sophia’s children hospital in need of a PIV.
Intervention: Patients will be randomized to one of three methods. The PIV procedure will be performed with support of the VeinViewer® (intervention A) or the Astodia® (intervention B) or without support. The VeinViewer® and the Astodia® consist of a near-infrared light or LED, which is over or placed underneath the puncture site. In the control group PIV insertion will take place without guidance from the VeinViewer® or the Astodia® unless visualization is considered necessary. In that case a secondary randomization will be performed to select either intervention A or B. This group will be described separately from the study population.
Main study parameters/endpoints: The main study parameter is the percentage of procedures, which are successful in one attempt. The secondary study parameters will be the total number of punctures necessary for a PIV insertion and the duration of the insertion procedure.
|- Main changes (audit trail)|
|- RECORD||26-jun-2013 - 1-jul-2013|