Deshpande 2009.
Study characteristics | ||
Methods | Double blind randomised controlled trial done at the department of neonatal paediatrics at KEM Hospital in Perth, Western Australia. Study enrolment from 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 who were < 7 days at recruitment with parenteral nutrition 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 lipid emulsion given before enrolment. Withdrawal: Enteral nutrition > 25% at any time. |
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Interventions | Total of 50 infants were randomised; the detailed results were available for 45 infants (24 infants in ClinOleic® group; 21 in Intralipid® group) OS‐LE vs S‐LE. 1) ClinOleic® (n = 25) 2) Intralipid® (n = 25) TPN protocol: The amino acids were added on day 1 and lipids added on day 2 in increments of 0.5, 1 , 2, 3 g/kg/day every day for 4 consecutive days. The lipid emulsion was in coded amber coloured syringes. The lipid infusion was given for 20 hours per day. The bloods were done 2 hours after stopping the lipid infusion. |
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Outcomes | The primary outcomes of the study were: a) Plasma F2‐isoprostane levels as indicators of lipid peroxidation. b) Levels of long chain polyunsaturated fatty acids in plasma and in RBC membrane. The secondary outcomes were: a) Safety outcomes ‐ liver and renal function tests, blood culture positive sepsis, blood cell counts. b) Total enteral nutrition and PN. c) Anthropometry |
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Notes | 1. Funding: Study was partly funded by research grant from Baxter Healthcare Australia and this funding was used for cost of laboratory assays and fat emulsions. Baxter health had no involvement in study design, data analysis or manuscript preparation. 2. One death on day 3 due to IVH in the olive oil group and shown in study diagram. Two more deaths occurred due to respiratory failure during the study period however information regarding which group these patients 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. |
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: Two more deaths occurred due to respiratory failure during the study period however information regarding which group these patients belonged to was not available. There was 1 patient in the ClinOleic® group and 4 patients in the Intralipid® group who were withdrawn from the study due to enteral energy intake > 25%. Their data is not available. Probably low risk. |
Selective reporting (reporting bias) | Unclear risk | Comment: The protocol for the study was not available to us so we can 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. |
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: The blinding of participants and personnel is acceptable in this study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote:"The data were analysed without breaking the code to ensure masking of statistical analysers" Comment: Probably done. |