Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants: Randomized Controlled Multicenter Study of Edelvaiss Multiline NEO Device
概览
- 阶段
- 不适用
- 干预措施
- Edelvaiss Multiline NEO
- 疾病 / 适应症
- Bacteremia
- 发起方
- University Hospital, Lille
- 入组人数
- 87
- 试验地点
- 4
- 主要终点
- Measure of incidence density (ID) of catheter-related bacteremia (CRB)
- 状态
- 终止
- 最后更新
- 10天前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •Infants with gestational ages between 24 and 29 weeks.
- •Infants carrying a single-lumen central venous catheter.
- •Obtaining the informed parental consent.
排除标准
- •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.
研究组 & 干预措施
Edelvaiss Multiline NEO
The Edelvaiss Multiline NEO design allows to position the access to the infusion line outside of the incubator, without increasing the residual volume and this device has been validated by the manufacturer as part of CE marking for a period of 21 days.
干预措施: Edelvaiss Multiline NEO
Standard Infusion Set
The infusion set used for the standard group is the infusion set usually used.
干预措施: Standard Infusion Set
结局指标
主要结局
Measure of incidence density (ID) of catheter-related bacteremia (CRB)
时间窗: Through an average of 30 days
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.
次要结局
- Measure of ID of occlusion of components of the infusion system(Through an average of 30 days)
- Number of septic shock(Through an average of 30 days)
- Total duration of oxygen therapy(Through an average of 30 days)
- Number of bronchopulmonary dysplasia(Through an average of 30 days)
- Total duration of mechanical ventilation(Through an average of 30 days)
- Total duration of parenteral nutrition(Through an average of 30 days)
- Cost of care for patients(Through an average of 30 days)