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van CCT (UK)

van CCT (UK)

Incidence of migration and thrombus formation of umbilical venous catheters in infants

- candidate number24380
- NTR NumberNTR5866
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mei-2016
- Secondary IDs57948 ABR-nummer
- Public TitleIncidence of migration and thrombus formation of umbilical venous catheters in infants
- Scientific TitleIncidence of migration and thrombus formation of umbilical venous catheters in infants
- hypothesis
- Healt Condition(s) or Problem(s) studiedUmbilical venous, Thrombus formation, Migration
- Inclusion criteria Study group: all infants receiving an umbilical venous catheter will be included (case).
Control group: For every included infant in the study group the next infant admitted to our ward without umbilical catheters will be included (control).
Matching case and control infants:
o For cases ≥30 weeks gestational age we will match a control with the same gestational age at birth (+/- 1 week).
o For cases < 30 weeks, matched controls are not available since all infants <30 weeks receive routinely umbilical catheters. For this group we will include infants without catheters with a gestational age of 30-32 weeks as controls.
- Exclusion criteriaNone
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jul-2016
- planned closingdate1-jul-2017
- Target number of participants102
- InterventionsCase: Ultrasound on day 1, 3, 7 and 14 of catheter, the day of removing the catheter and whenever a chest X-ray is made on another day.
Control: Ultrasound on day 1, 7 and 14 after birth (or day of discharge when between day 1 and 14).
- Primary outcomeThe frequency of thrombus formation in the umbilical venous catheter route or heart in infants with and without umbilical-vein catheters.
- Secondary outcomeThe amount of migrated umbilical venous catheters, the amount of umbilical venous catheters migrated to incorrect positions and the amount of umbilical venous catheters migrated to incorrect positions not detected by the chest X-ray made as standard of care.
- TimepointsSee interventions
- Trial web site
- statusplanned
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryUmbilical venous catheters (UVCs) are frequently required for the management of critically ill infants. Formation of thrombi is described as a possible complication in infants with UVCs. The indication for treatment of these thrombi is controversial and different departments use different criteria. It is also possible that this thrombus formation, especially in the ductus venosus, is a physiological process and not pathologic. Risk of formation of thrombi is increased in case of malposition of UVCs. The ideal location for umbilical-vein catheter-tips is at the junction between the inferior vena cava and the right atrium (IVC/RA-junction). The position of umbilical catheters is checked after umbilical catheterization and catheters are repositioned if necessary. We clinically observed that UVCs after placement often migrate in the following days, despite fixation of the catheter with sutures in the umbilical cord and tapes to the abdominal wall. Although there is abundant amount of literature investigating the placement and location of the UVC, little is known about the migration after placement, how often this occurs, what are the risk factors, how much it migrates and whether the location of the tip is still acceptable. Migration may possibly lead to more complications.
In this prospective observational case-control study infants receiving UVCs are included as cases and infants without UVCs as controls. Serial ultrasound examination is performed to identify thrombi and their location and to identify the location of the tip of the catheter in infants with UVCs. We determine the incidence and location of thrombi in the umbilical venous catheter route during and after umbilical catheterization and in the same route in infants without umbilical catheters. We also investigate the frequency of migration of umbilical venous catheters in infants and identify risk factors for this migration.
- Main changes (audit trail)
- RECORD20-mei-2016 - 23-aug-2016

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