Skouroliakou 2010.
| Methods | Design: RCT in preterm infants Setting: single‐centre NICU of 'IASO' Maternity Hospital in Athens, Greece Study enrolment: Nov 2008 to April 2009 I. Allocation concealment: yes II. Blinding of intervention: yes III. Blinding of outcome measurement(s): yes IV. Complete follow‐up: no |
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| Participants | 38 infants enrolled Inclusion criteria: preterm infants < 32 weeks' gestation with birth weight < 1500 g requiring admission to NICU within 12 hours of birth and expected to receive > 80% of the energy intake by parenteral route in the first 8 days of life and requiring PN for at least 7 days. Exclusion criteria: inherited metabolic disorders, congenital malformations, transfusion of blood/fresh frozen plasma > 15 mL/kg and participation in another study |
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| Interventions | Group 1 (n = 19): MOFS‐LE; SMOFlipid Group 2 (n = 19): S‐LE; Intralipid 4 different TPN protocols were created based on gestational age, weight and clinical condition. Lipids were started on day 1 or 2 of life (based on gestational age) with a maximum of 3 g/kg/day in both the groups. Enteral feeds were allowed at ≤ 20% of total energy intake and started as soon as feasible. Oral feeds were started after at least 14 days of PN for all infants in the study group. |
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| Outcomes | Primary outcome: oxidation potential (vitamins A and E, and total anti‐oxidant potential) Hypothesis: a reduction in oxidative stress in the SMOFlipid group? Secondary outcomes: growth parameters, blood count, clinical condition and length of stay (parameters noted on day 0, day 14 and at discharge). |
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| Notes | SMOFlipid was supplied by Fresenius Kabi. Vitamin A and E levels were not affected by the intervention, however TAP level was increased in the SMOFlipid group, indicating possible reduction in the oxidant stress. Authors mentioned: "none of the children in each group had any side effects related to parenteral nutrition or sepsis." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Computer generated randomisation." Comment: probably done. |
| Allocation concealment (selection bias) | Low risk | Quote: "the pharmacist, who was responsible for the placement of each infant in a group (intervention vs control) …" Comment: statistician and pharmacist not involved in the trial. Probably done. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "PN were in identical bags." Comment: probably done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "PN were in identical bags;" " All medical personnel and participants were blinded to treatment assignment during the whole course of the study." Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: out of 38 randomised infants there were 6 exclusions (16%) with 5 from the SMOFlipid group (n = 2 transfusion > 15 mL/kg, n = 1 PN < 7 days, n = 1 transfer to another centre) and 1 from the 20% Intralipid group (PN < 7 days) (unbalanced exclusions) |
| Selective reporting (reporting bias) | Unclear risk | Comment: protocol for the study was not available so we could not ascertain any deviation from the protocol. |
| Other bias | Low risk | None identified. |