Randomized monocentric study on the optimal length of stay (8-14 vs. <7 days) of umbilical vein catheters in premature babies with a birth weight of <1500 grams "UVC - You Will See Study"

Randomized monocentric study on the optimal length of stay (8-14 vs. <7 days) of umbilical vein catheters in premature babies with a birth weight of <1500 grams "UVC - You Will See Study" - UVC - You Will See Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00022262

Enrollment

Registered

2020-06-26

Start date

2020-07-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07 P07.1

Interventions

Group 1: 1) Umbilical vein catheter duration = 7 days, then change to PICC catheter or peripheral venous indwelling catheter (PVK) if necessary. Group 2: 2) Umbilical vein catheter duration 8-14 days,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: If there is parental consent and there are no exclusion criteria, very immature premature babies with a birth weight <1500 grams are included, for whom the insertion of an umbilical vein catheter is necessary to carry out (partial) / parenteral nutrition.

Exclusion criteria

Exclusion criteria: Lack of parental consent / lack of consent from the custodian. Birth weight = 1500 grams. There are contraindications (e.g. congenital defects of the abdominal wall, inflammation in the area of the navel or umbilical vessels).

Design outcomes

Primary

Measure	Time frame
Number (total) of the central venous catheters used (ZVEK / PICC) up to the time of complete enteral feeding (140-160 ml / kg / day) including NVK.	—

Secondary

Measure	Time frame
Secondary outcome parameters: The following complications are recorded: a) Catheter-associated infections (secondary outcome parameters) as defined by KRINKO and administration of antibiotics and number of antibiotic days in both groups (total number and recording specific for the different antibiotics (Unacid, Gentamicin, Teicoplanin, Clarythromycin and Meropnem) b) Catheter-associated thrombosis (secondary outcome parameter) c) Catheter-associated mechanical complications (e.g. pericardial injury) (secondary outcome parameters) Other relevant outcome parameters to be recorded: a) Rate: respiratory distress syndrome (ANS) and bronchopulmonary dysplasia (BPD) b) Rate: Necrotizing Enterocolitis (NEC) c) Rate: Premature Retinopathy (ROP) d) Rate: Intraventricular Hemorrhages (IVH) e) Rate: Periventricular leukomalacia f) Mortality up to the time of discharge or transfer	—

Measure

Time frame

Secondary outcome parameters: The following complications are recorded: a) Catheter-associated infections (secondary outcome parameters) as defined by KRINKO and administration of antibiotics and number of antibiotic days in both groups (total number and recording specific for the different antibiotics (Unacid, Gentamicin, Teicoplanin, Clarythromycin and Meropnem) b) Catheter-associated thrombosis (secondary outcome parameter) c) Catheter-associated mechanical complications (e.g. pericardial injury) (secondary outcome parameters) Other relevant outcome parameters to be recorded: a) Rate: respiratory distress syndrome (ANS) and bronchopulmonary dysplasia (BPD) b) Rate: Necrotizing Enterocolitis (NEC) c) Rate: Premature Retinopathy (ROP) d) Rate: Intraventricular Hemorrhages (IVH) e) Rate: Periventricular leukomalacia f) Mortality up to the time of discharge or transfer

—

Countries

Germany

Contacts

Public ContactSascha Meyer

Klinik für Allgemeine Pädiatrie und Neonatologie, Universitätsklinikum des Saarlandes

sascha.meyer@uks.eu06841-16-28313

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026