Seliem 2010.
Methods | Randomised, blinded, controlled trial | |
Participants | 97 neonates, enrolled between February 2008 and February 2009; 83 included in the analysis Mean birthweight: 2434 g and 2005 g Gestation age: 33.5 weeks and 33.1 weeks Setting: NICU at Mansoura University Children's Hospital, Mansoura, Egypt Inclusion criteria: all neonates who were expected to require a UVC for ≥ 48 hours Exclusion criteria: neonates with an indwelling UVC for > 24 hours without a lock technique, and infants who received systemic antibiotic therapy or who were transferred to other hospitals in the first day of life |
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Interventions | Intervention: 0.4 mL heparinised saline containing amikacin (1.5 mg/mL) (Protocol B) for 20 minutes twice a day Control: 0.4 mL heparinised saline (10 IU/mL) (Protocol A) for 20 minutes twice a day UVCs used were single lumen 5.0 French gauge polyvinyl chloride end hole catheters. Catheters were inserted using maximal sterile barriers, including the use of sterile gloves, gown, mask and large drape. The site was disinfected with 10% povidone‐iodine and inserted to keep the tip just above the diaphragm, catheters higher than this were pulled back following x‐ray, catheter lower than this were removed and re‐inserted. The umbilical stump was cleansed on a daily basis with 70% alcohol. IV tubing was changed every 24 hours using strict sterile technique by 2 nurses, 1 wearing sterile gloves, cap, gown and mask to handle all the sterile equipment. Catheter hubs were cleansed with 70% alcohol whenever the hubs were accessed. Catheters were removed when no longer required or on day 14 |
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Outcomes |
Definite CRBSI: positive peripheral BC concomitant with positive BC from catheter or catheter tip grew the same species AND clinical sign of sepsis AND no other apparent source of infection Probable CRBSI: positive peripheral BC and positive catheter BC grew a different species OR positive BC from the catheter or catheter tip and the peripheral sample was sterile in the presence of clinical signs of infection Definite and probable CRBSI: definite and probable combined BSI without a source: positive peripheral BC with clinical signs of infection and a negative BC withdrawn from the catheter or catheter tip culture All BSI Hypoglycaemia (< 45 mg/dL): measured at the end of the dwell time Amikacin resistance: axillary and rectal swabs and entry and end of the study, growth on amikacin‐containing agar considered resistant |
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Notes | 30 bed, level 3 NICU Mean (± SD) catheter‐days: control 10.3 (3.6); intervention 11.6 (2.1) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | There was no explanation to how the sequence was generated |
Allocation concealment (selection bias) | Low risk | Quote: "Neonates randomised using opaque sealed envelope containing the randomisation sequence" Opaque sealed envelopes kept in a locked cabinet |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All participants and clinicians were blind to the nature of the locking solution Quote: "Only the research nurse was aware of the nature of the locking solution and responsible for its preparation according to the protocol" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All analyses were performed by investigators who were blinded to group assignment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis with 626 neonates admitted to NICU 105 required a UVC, 4 parents refused consent, 2 study personnel not available, 2 infants received systemic antibiotic, 97 neonates randomised Participants excluded after randomisation were appropriately explained 11 UVCs were removed within 48 hours, 3 neonates died before 48 hours, therefore, did not meet eligibility criteria |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk |
BC: blood culture; BSI: bloodstream infection; CRBSI: catheter‐related bloodstream infection; CVC: central venous catheter; DNA: deoxyribonucleic acid; IU: international unit; IV: intravenous; NICU: neonatal intensive care unit; PICC: peripherally inserted central catheter; SD: standard deviation; UVC: umbilical venous catheter.