Comparing the Effectiveness of a Safety Intravenous Cannula With a Standard Intravenous Cannula in Neonates
Condition: Preterm Infant
Study type: Interventional

Summary: 
      A smaller caliber of intravenous cannulae decreases the number of thrombi and phlebitis and
      improves the duration of peripheral access. It also reduces the incidence of extravasation.
      26G cannulae are easier to insert and reduce the number of attempts for cannulation. Safety
      cannulae are equivalent in terms of durability and ease of insertion, additionally providing
      a reduction in needle stick injury amongst healthcare professionals and patients.

      The goal of this study is to reduce the number of peripheral line insertions and resulting
      complications in neonates.

      The Investigators propose to compare 24G safety and 26G safety cannulae with non-safety 24G
      cannulae in infants < 32 weeks Gestation and < 1.5 kg weight in terms of length of stay of
      cannula, ease of insertion and rates of complications such as thrombosis, phlebitis and
      extravasation.

      The Investigators will also evaluate the frequency of needle stick injury to staff and
      patients in the course of the study.
    

Detailed description: 
      Peripheral venous cannulation is a common procedure on neonatal NICU. Insertion of peripheral
      cannulae in neonates is a painful and stressful procedure (5) and it is therefore desirable
      to minimize the number of procedures by increasing the survival time of each cannula. The
      incidence of phlebitis is variously described as 20 - 80% (2). Failure of venous access is
      often due to thrombi, phlebitis and extravasation. Mechanical phlebitis can be avoided by
      using the smallest gauge cannula capable of delivering the prescribed drug. (1) Mechanical
      phlebitis occurs where there is movement of a foreign object (cannula) within a vein causing
      friction and subsequent inflammation(3). Success rates for cannulation depend on a range of
      factors including the clinician's experience, gauge of cannula and infants weight as well as
      the condition of veins. Median survival of 24G Teflon intravenous cannulae was described as
      40 hours in one study (4). There are few studies on the appropriate sizing of intravenous
      cannulae in children.

      Flow rates for intravenous devise vary greatly depending on the manufacturer. Flow rates for
      24G cannulae are 13 - 29 ml/min. The 26G cannulae achieve flow rates of 13 -19 ml/min which
      is adequate for use on NICU. The most commonly used devise on NICU SMH are 24G cannulae with
      a flow rates between13ml/min and 25 ml/min depending on manufacturer.

      In this study the proposed non-safety 24 G cannula achieves a flow rate of 25 ml/min whereas
      the safety 24G and 26 G cannula achieve 22ml/ min and 15ml/min respectively.

      Within the EU safety devices are mandatory since 2010 (6). Needle stick injuries during
      venepuncture pose a risk for healthcare professionals and other staff due to the transmission
      of blood borne pathogens such as Hepatitis B, Hepatitis C and HIV. This has cost implications
      for the NHS.

      Safety cannulae in both 24 and 26 G have been trialed on the investigator's NICU in 2017 and
      are felt to be an important addition providing both safe and reliable cannulation. The design
      of the safety cannula is very similar to cannulae already used on the unit and handling does
      not require change in practice.

      Due to the winged design of both safety and non-safety cannulae fixation of the line post
      insertion can be standardized.
    

Intervention name(s): IVcannulation
Intervention type(s): Device
Intervention description(s): Peripheral venous cannulation is a common procedure on neonatal NICU, especially in preterm infants
Other intervention name(s): 24G non-safety cannula,26G safety cannula,24G safety cannula
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Once consent is obtained, patients will be randomized to either 24G non-safety cannula, 24G safety or 26G safety cannula. Each patient can enter the study a maximum of three times providing 90 episodes of cannulation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral Intravenous cannulation