D'ascenzo 2014.
Study characteristics | ||
Methods | Premature neonates were recruited from the NICU at the Salesi Children’s Hospital, Rome, Italy, between January 2008 and 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 premature 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: 1) MOFS‐LE 2.5 (n = 21): MOFS‐LE (30% soybean oil, 30% medium‐chain triglycerides, 25% olive oil, 15% fish oil), SMOFlipid® Fresenius Kabi. 2) MOFS‐LE 3.5 (n = 18): MOFS‐LE (30% soybean oil, 30% medium‐chain triglycerides, 25% olive oil, 15% fish oil), SMOFlipid® Fresenius Kabi. 3) S‐LE 2.5 (n = 22): S‐LE (100% soybean oil), Intralipid® Fresenius Kabi. 4) S‐LE 3.5 (n = 19): S‐LE (100% soybean oil), Intralipid® Fresenius Kabi. |
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Outcomes | Primary outcome: Plasma phospholipid and DHA (mol%) on postnatal day 7. Secondary outcome: On postnatal day 7 and 14, levels of plasma fatty acids and plasma lipid concentration, triglyceride levels, free cholesterol and cholesterol esters. 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. |
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 to us so we can not ascertain any deviation from the protocol. |
Other bias | Low risk | Comment: None identified. |
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. |