van den Hoogen 2006.
Methods | Parallel, quasi‐randomised controlled trial | |
Participants | 442 neonates requiring IV fluids via an umbilical or percutaneous central venous catheter or a catheter inserted in the subclavian or femoral vein. All neonates admitted to the neonatal intensive care unit and required fluids via a central venous catheter were eligible Gestation: 25 ‐ 43 weeks Birth weight: 600 ‐ 4640 gm |
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Interventions | Experimental group: 0.22 micron intravenous filter (N = 228) Control group: No filter (N = 214) Catheter tips cultured after removal Administration set changed daily in the control group. Administration set changed every 96 hours in treatment group | |
Outcomes | 1. Mortality 2. Phlebitis: defined as 'signs of local infection and a positive culture from the infected site' 2. Proven Sepsis: defined as 'occurrence of clinical signs of local infection and a positive blood culture' 3. Number of catheter days 4. Length of stay in hospital 5. Financial costs |
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Notes | Sample size calculation: Not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Each baby that required intravenous infusion was entered into the study with alternate babies having an in‐line filter |
Allocation concealment (selection bias) | High risk | No |
Blinding (performance bias and detection bias) All outcomes | High risk | No |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for 65 infants were excluded post randomisation 'because the patient was discharged soon after birth, died after a few days, or because of incomplete data (approximately 14% loss to follow‐up). |
Selective reporting (reporting bias) | Unclear risk | We were unable to obtain the study protocol. There was incomplete reporting on reasons for catheter removal and reinsertion for both treatment and control group |