Deshpande 2009.
Methods | Design: double‐blind RCT Setting: Department of Neonatal Paediatrics at KEM Hospital in Perth, Western Australia. Study enrolment: November 2006 to August 2007 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: preterm infants < 28 weeks' gestation aged < 7 days at recruitment with PN accounting for > 75% of energy intake. Exclusion criteria: major congenital malformations, inborn errors of metabolism, transfusion before baseline bloods could be taken, exchange transfusion for hyperbilirubinaemia or LE given before enrolment. Withdrawal: enteral nutrition > 25% at any time. |
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Interventions | 50 infants were randomised; the detailed results were available for 45 infants (24 infants in ClinOleic group; 21 in Intralipid group) Group 1 (n = 25): OS‐LE; ClinOleic Group 2 (n = 25): S‐LE; Intralipid TPN protocol: the amino acids were added on day 1 and lipids added on day 2 in increments of 0.5 g/kg/day, 1 g/kg/day, 2 g/kg/day, 3 g/kg/day every day for 4 consecutive days. LE was in coded amber‐coloured syringes. The lipid infusion was given for 20 hours/day. Bloods was taken 2 hours after stopping the lipid infusion. |
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Outcomes | Primary outcomes: plasma F2‐isoprostane levels as indicators of lipid peroxidation; levels of LC‐PUFAs in plasma and RBC membrane. Secondary outcomes: safety outcomes: liver and renal function tests, blood culture positive sepsis, blood cell counts; total enteral nutrition and PN; anthropometry |
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Notes | Funding: study partly funded by research grant from Baxter Healthcare Australia and this funding was used for cost of laboratory assays and fat emulsions. Baxter Healthcare had no involvement in study design, data analysis or manuscript preparation. 1 death on day 3 due to IVH in the olive oil group and shown in study diagram. 2 more deaths occurred due to respiratory failure during the study period, however, information regarding which group these participants belonged to was not available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The coordinating pharmacist who was not directly involved in the management of patients performed block randomisation using a computer‐generated code." Comment: probably done. |
Allocation concealment (selection bias) | Low risk | Quote: "The coordinating pharmacist who was not directly involved in the management of patients performed block randomisation using computer‐generated code." "lipid emulsions were dispensed in coded and amber‐coloured (light protected) syringes." Comment: probably done. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The lipid emulsions were dispensed in coded and amber‐coloured (light protected) syringes." Comment: blinding of participants and personnel was acceptable in this study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The data were analyzed without breaking the code to ensure masking of statistical analysers." Comment: probably done. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "One participant in the OL group died on day 2 (grade IV IVH) but was included in the analysis on intention to treat basis; however, there was no blood sample on day 6 for the patient." Comment: 2 more deaths occurred due to respiratory failure during the study period, however, information regarding which group these participants belonged to was not available. There was 1 participant in the ClinOleic group and 4 participants in the Intralipid group who were withdrawn from the study due to enteral energy intake > 25%. Their data were not available. Probably low risk. |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol for the study was not available to us so we could not ascertain any deviation from the protocol. The data on outcomes of sepsis and weight were not available (could not be used in meta‐analysis). |
Other bias | Low risk | Comment: no other biases identified. |