Köksal 2011.
Methods | Design: single‐centre blinded RCT Setting: NICU of Division of Neonatology, Görükle, Bursa, Turkey Study enrolment: September 2005 to December 2009 I. Allocation concealment: yes II. Blinding of intervention: yes III. Blinding of outcome measurement(s): yes IV. Complete follow‐up: yes |
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Participants | Inclusion criteria: ≤ 34 weeks' gestation, admission to NICU within 24 hours after birth and TPN requirement expected to be ≥ 80% of the total energy intake during the study. Exclusion criteria: severe malformations, hyperlipidaemia, metabolic disease, enteral nutrition > 20 mL/kg/day and transfusion > 15 mL/kg/day |
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Interventions | Group 1 (n = 32): OS‐LE; 20% ClinOleic Group 2 (n = 32): S‐LE; 20% Intralipid LE was started within 72 hours after the baseline blood sample was obtained. LE was infused at 1 g/kg/day, 2 g/kg/day and 3 g/kg/day on first 3 days and 3 g/kg/day over the next 4 days in both groups. After 7 days of LE, infusion was stopped and blood samples taken after 6 hours. Study end point was day 7 for total antioxidant capacity (primary outcome). The secondary clinical outcomes have been reported until discharge. |
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Outcomes | Primary outcome: total anti‐oxidant capacity in both LEs at day 7 (not significantly different between groups) Secondary outcomes: neonatal morbidity and the biochemical indices after LE administration. Biochemical indices were also compared at day 7. The neonatal morbidities have been reported to discharge (including ROP, BPD, IVH, NEC, RDS and sepsis). |
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Notes | No source of funding stated. No growth outcomes provided in the study report; however, these were provided by the study authors on request. Unpublished data provided by the authors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Block randomisation was performed using a computer‐generated code." Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote: "The coded emulsion was prepared and labelled by the blinded clinical pharmacist." Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Parents, trial physicians and clinical staff were blinded to the lipid content of the TPN." "The coded emulsion was prepared and labelled by the blinded clinical pharmacist." Comment: probably done (by author consensus (VK, MM)) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Parents, trial physicians and clinical staff were blinded to the lipid content of the TPN." "The coded emulsion was prepared and labelled by the blinded clinical pharmacist." Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcomes were reported for all participants. |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol for study was not available so we could not ascertain any deviation from the protocol. |
Other bias | Unclear risk | Comment: study contributed to high heterogeneity in the outcomes of ventilation duration and duration of oxygen therapy (SD data confirmed by authors). The level of sickness of patients has not been described between the two groups. |