Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.

Bacteremia Clinical Trial

— MultilineNEO  

Official title:

Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants: Randomized Controlled Multicenter Study of Edelvaiss Multiline NEO Device

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02633124
• Other study ID #: 2014_67
• Secondary ID: 2015-A00585-44
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants. This device will be compared to the standard infusion set of each center.

Description:

Edelvaiss® Multiline NEO is a multi-lumen infusion access device, adapted to the neonatal population. It has five ports connected to five lumens separated in a single tube of 90 cm, combined with a small single tube called annex port. Four ports numbered 1 to 4 are connected to four peripheral lumens (residual volume per lumen: 0.6 mL). The fifth port, called central access (indicated by the HF icon (High Flow)), is reserved to the administration of parenteral nutrition. It is connected to the central lumen (residual volume: 4.5 mL). The sixth port on the annex way allows an administration closer to the infant (residual volume: 0.40 mL). It is thus reserved for emergencies and direct intravenous injections. The innovative technological design of Edelvaiss® Multiline NEO device should enable secure administration of injectable drugs by preventing variations in drug mass flow rate and the occurrence of drug incompatibilities. This device would reduce the number of perfusion incidents and therefore, the frequency of manipulations of infusion lines within the incubator, direct source of occurrence of bacteremia. Moreover, its main interest lies in neonatology in the possibility of being positioned outside of the incubator and to have a lifetime of 21 days, contributing to the prevention of catheter-related bacteremia. All manipulations are therefore made outside the incubator at the room temperature and the relative humidity, and at a distance from the device/catheter junction.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 29 Weeks

Eligibility

Inclusion Criteria:

• Infants with gestational ages between 24 and 29 weeks.
• Infants carrying a single-lumen central venous catheter.
• Obtaining the informed parental consent.

Exclusion Criteria:

• Infants carrying a multi-lumen central venous catheter.
• Infants carrying a umbilical venous catheter.
• Infants carrying two central venous catheters.
• Refusal of informed parental consent.

Related Conditions & MeSH terms

• Bacteremia
• Birth Weight
• Infant, Very Low Birth Weight
• Premature Birth

Intervention

Device:
• Edelvaiss Multiline NEO
Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period
• Standard Infusion Set
Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period

Locations

Country	Name	City	State
France	Chu Amiens Picardie	Amiens
France	Hôpital Côte de Nacre - CHU de Caen	Caen
France	Hôpital Jeanne de Flandre - CHRU de Lille	Lille
France	Hôpital Charles Nicolle - CHU de Rouen	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (2)

Erdei C, McAvoy LL, Gupta M, Pereira S, McGowan EC. Is zero central line-associated bloodstream infection rate sustainable? A 5-year perspective. Pediatrics. 2015 Jun;135(6):e1485-93. doi: 10.1542/peds.2014-2523. Epub 2015 May 18. — View Citation

Mahieu LM, De Dooy JJ, Lenaerts AE, Ieven MM, De Muynck AO. Catheter manipulations and the risk of catheter-associated bloodstream infection in neonatal intensive care unit patients. J Hosp Infect. 2001 May;48(1):20-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of incidence density (ID) of catheter-related bacteremia (CRB)	Catheter-related bacteremia (CRB) are the most frequent nosocomial infections in Neonatal Intensive Care Unit (NICU) patients. Nosocomial CRB in the NICU contribute significantly to hospital morbidity as well as to increased costs due to prolonged hospitalization.; The main objective is to assess the interest of the Multiline NEO in preventing CRB when administering injectable medications in NICU patients. It is whether the Multiline NEO device reduces the risk of CRB in premature infants hospitalized in NICU.; Measure of ID of CRB as criteria of Neocat Network during central venous catheterization in the patient.	Through an average of 30 days
Secondary	Measure of ID of occlusion of components of the infusion system	Measure of ID of occlusion of components of the infusion system is determined on the period of central venous catheterization in the patient.	Through an average of 30 days
Secondary	Number of septic shock	The number of septic shock defined by the use of vasoactive drugs during central venous catheterization in the patient.	Through an average of 30 days
Secondary	Total duration of oxygen therapy	Total duration of oxygen therapy is determined from the inclusion of the patient in the study until the end of his hospitalization.	Through an average of 30 days
Secondary	Total duration of mechanical ventilation	Total duration of mechanical ventilation is determined from the inclusion of the patient in the study until the end of his hospitalization.	Through an average of 30 days
Secondary	Total duration of parenteral nutrition	Total duration of parenteral nutrition is determined from the inclusion of the patient in the study until the end of his hospitalization.	Through an average of 30 days
Secondary	Number of bronchopulmonary dysplasia	Number of bronchopulmonary dysplasia defined by the Walsh test is determined from the inclusion of the patient in the study until the end of his hospitalization.	Through an average of 30 days
Secondary	Cost of care for patients	Cost of care for patients includes : cost of components of the infusion lines, including their replacement,; cost of nursing time dedicated to handling lines,; cost of identifying a CRB,; cost of hospital stay. Cost of care for a patient is calculated from the inclusion of the patient in the study until the end of his hospitalization.	Through an average of 30 days

External Links

•   Website of the Multiline NEO manufacturer (Doran International)