Skouroliakou 2016.
| Methods | Design: single‐centre RCT in preterm neonates Setting: NICU of "IASO" Maternity Hospital Thessaloniki, Greece Study enrolment: September 2012 to September 2013 |
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| Participants | Inclusion criteria: infants with 26–32 weeks' gestational age, anticipated need for PN > 60% of total energy requirements for ≥ 15 days, parental consent for participation to the study | |
| Interventions | 51 infants enrolled Group 1 (n = 26): MOFS‐LE; 20% SMOFlipid (Fresenius Kabi HELLAS; contained MCTs (30%), lipids from soybean oil (30%), olive oil (25%), fish oil (15%) and α‐tocopherol (200 mg/L)) Group 2 (n = 25): S‐LE; 20% Intralipid (Fresenius Kabi HELLAS; conventional soybean oil‐based 20% Intralipid that contained α‐tocopherol 38 mg/L) Infant followed up 30 days of life or until the PN‐derived energy decreased to < 40% of total daily energy requirements. |
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| Outcomes | Primary outcome: tumour necrosis factor‐α, IL‐6 and IL‐8 Secondary outcomes: plasma α‐tocopherol and FA profiles Clinical outcomes: death, RDS requiring treatment, BPD, clinical and culture‐confirmed sepsis, liver enzymes and cholestasis |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Simple randomisation was based on a computer‐generated randomisation list." Comment: done |
| Allocation concealment (selection bias) | Low risk | Quote: "The list was given to the pharmacist, who prepared the different PN formulations in identical bags and assigned neonates in 1 of 2 groups. The pharmacist was not involved in neonates' care." Comment: done |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All medical personnel and participants were blinded to treatment assignment during the whole study period." Comment: probably done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All medical personnel and participants were blinded to treatment assignment during the whole study period." Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Of the 60 recruited neonates, 51 completed the study. Nine neonates (4 and 5 from the IG [intervention group] and CG [control group], respectively) were excluded after randomisation." Comment: this is similar to a per‐protocol study flow and analysis rather than ITT with concerns regarding incomplete outcome data from both arms. However as the exclusions were equally distributed in both arms, we assigned 'unclear risk' of bias (by author consensus). |
| Selective reporting (reporting bias) | Unclear risk | Quote: "The trial has not been included in a Clinical Trials database because the relevant database in Greece is reserved for phase III trials for novel treatments." Comment: selective reporting could not be ascertained as we did not have access to the trial protocol. |
| Other bias | Low risk | None detected |