D'Ascenzo 2014.
Methods | Setting: NICU of Salesi Children's Hospital, Rome, Italy Study enrolment: January 2008 to December 2012 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, birth weight 500–1249 g Exclusion criteria: severe congenital malformations or no consent |
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Interventions | 80 preterm infants were randomised in 1:1:1:1 ratio to receive either SMOFlipid or Intralipid at rate of either 3.5 g/kg/day or 2.5 g/kg/day in 4 groups: Group 1 (n = 21): MOFS‐LE 2.5: MOFS‐LE (30% soybean oil, 30% MCT, 25% olive oil, 15% fish oil), SMOFlipid Fresenius Kabi. Group 2 (n = 18): MOFS‐LE 3.5: MOFS‐LE (30% soybean oil, 30% MCT, 25% olive oil, 15% fish oil), SMOFlipid Fresenius Kabi. Group 3 (n = 22): S‐LE 2.5: S‐LE (100% soybean oil), Intralipid Fresenius Kabi. Group 4 (n = 19): S‐LE 3.5: S‐LE (100% soybean oil), Intralipid Fresenius Kabi. |
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Outcomes | Primary outcome: plasma PL and DHA (mol%) on postnatal day 7. Secondary outcomes: on postnatal day 7 and 14, levels of plasma FAs and plasma lipid concentration, TG levels, FC and CEs. Other outcomes reported: death and clinical outcomes. |
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Notes | Funding source: none revealed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "At birth, the caring neonatologist randomised the study infants by a simple randomisation method (sealed envelope system)." Comment: probably done as the previous reports involving the same team has mentioned it in their previous report: "Randomization was obtained with sealed envelopes using a random permuted blocks within strata protocol" (decision by consensus between the review authors). |
Allocation concealment (selection bias) | Low risk | Quote: "sealed envelope system." Comment: low risk of bias. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The PN bags containing the study lipid emulsion were of the same size and of identical appearance. Both the caregivers involved with data collection and the laboratory personnel were blind to group assignment." Comment: probably done. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The PN bags containing the study lipid emulsion were of the same size and of identical appearance. Both the caregivers involved with data collection and the laboratory personnel were blind to group assignment." Comment: probably done. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: follow‐up was complete. |
Selective reporting (reporting bias) | Unclear risk | Quote: "The trial was conducted between January 2008 and December 2012 so we had not registered it in a public trials registry as it is now required for trials that started after July 2008." Comment: study protocol was not available so we could not ascertain any deviation from the protocol. |
Other bias | Low risk | Comment: none identified. |