No registrations found.
ID
Source
Brief title
Health condition
Umbilical venous
Infant
Migration
Thrombus formation
Dutch:
Navelvenelijn
Pasgeborene
Migratie
Thrombusvorming
Sponsors and support
Intervention
Outcome measures
Primary outcome
The frequency of thrombus formation in the umbilical venous catheter route or heart in infants with and without umbilical-vein catheters.
Secondary outcome
The 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.
Background summary
Umbilical 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.
Study design
See interventions
Intervention
Case: 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).
G.H. Dubbink-Verheij
P.O.Box 9600
Leiden 2300 RC
The Netherlands
g.h.dubbink-verheij@lumc.nl
G.H. Dubbink-Verheij
P.O.Box 9600
Leiden 2300 RC
The Netherlands
g.h.dubbink-verheij@lumc.nl
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 criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5713 |
| NTR-old | NTR5866 |
| Other | ABR-nummer : 57948 |