None listed
Conditions
Brief summary
The primary purpose of the study was to evaluate whether a bundle of line management measures focused on reducing the risk of contamination of Parenteral Nutrition (PN) lines would reduce the incidence of Late Onset Sepsis (LOS) in Very Low Birth Weight babies. The hypothesis was that the study intervention; comprised of a strict sterile technique for line changes and minimising the administration of other medications or fluids through PN lines would reduce catheter contamination and by minimising breaches would reduce the incidence of LOS when compared to the standard technique routinely used in the Neonatal Intensive Care Unit.
Interventions
The study intervention technique consisted of parenteral nutrition (PN) line change management for very low birth weight infants. The PN line changes were undertaken by two experienced neonatal nurses, one having performed a surgical scrub followed by the wearing of a mask and clothing with sterile gown and gloves to prevent any breach of sterility. A full 'no touch' technique was employed.
Amino acid/dextrose solutions were changed every 48-72 hours. Solution changes were on Mondays, Wednesda
The study intervention technique consisted of parenteral nutrition (PN) line change management for very low birth weight infants. The PN line changes were undertaken by two experienced neonatal nurses, one having performed a surgical scrub followed by the wearing of a mask and clothing with sterile gown and gloves to prevent any breach of sterility. A full 'no touch' technique was employed. Amino acid/dextrose solutions were changed every 48-72 hours. Solution changes were on Mondays, Wednesdays and Fridays to fit in the pharmacy requirements. Intralipid/vitamin solution which was dispensed by the pharmacy was changed every 24 hours. Continuous infusions of medications were changed every 24 hours. Clear fluid (e.g. 0.9% sodium chloride) infusions were changed every 72 hours. PN lines were not used for other infusions, unless the infusion fluids were prepared and changed using the study intervention techniques as above. PN lines were only used for other medications in an emergency or if no other route could reasonably be used. 3-way taps were only fitted to PN infusion lines if other infusions (e.g. sedation) were administered concurrently. Filters (in-line) - Pall Neo 96 (Pall Life Sciences, Port Washington, NY) used for PN lines. A SmartSite(Smith Medical, St Paul, MN) directly connected to all venous catheters and venous extension tubing and left in situ at line change). PN line changes only occurred when there was tissue infiltration of fluids.
Sponsors
Mater Mothers' Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Days to 5 Days
Healthy volunteers
No
Inclusion criteria
Very low birth infants with a birth weight <1500 g were eligible if they survived at least 48 hours, and were considered by the clinical team to require Parenteral Nutrition.
Exclusion criteria
Infants were excluded if they were not expected to survive to randomisation, had major congenital anomalies (including any infant expected to need neonatal surgery in the first 28 days) or had early onset sepsis (positive blood or CSF culture at < 48 hours of life).
Outcome results
None listed