Beken 2014.
Methods | Design: RCT Setting: single‐centre NICU of Dr Sami Ulus Maternity and Children Research Centre in Ankara, Turkey Study enrolment: 1 January 2013 to 31 July 2013 I. Allocation concealment: yes II. Blinding of intervention: could not determine III. Blinding of outcome measurement(s): yes (for ROP) IV. Complete follow‐up: yes |
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Participants | Inclusion criteria: < 1500 g and < 32 weeks' gestation Exclusion criteria: major congenital abnormalities, congenital infections and metabolic errors |
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Interventions | 80 infants were randomly assigned. Group 1 (n = 40): MOFS‐LE; 20% SMOFlipid Group 2 (n = 40): S‐LE; 20% Intralipid TPN was started with intravenous glucose and amino acid solution 1 g/kg on first day of life. The LEs were administered from day 1 as a continuous infusion for 24 hour/day. Initial lipid daily dose 0.5 g/kg/day if birth weight < 1000 g and 1 g/kg/day if birth weight > 1000 g. Lipids were increased by 0.5–1.0 g/kg every 24 hours to a maximum of 3 g/kg/day. Infants in both arms also received trace elements, water and lipid‐soluble vitamins as a standard part of the TPN protocol. Both groups were started on enteral feeds with DHA‐enriched preterm formula or breast milk. |
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Outcomes | Primary outcome: ROP Secondary outcomes: cholestasis, nosocomial infections, NEC, CLD and mortality Laboratory data including complete blood count, TG levels, and liver and kidney function tests were recorded. |
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Notes | Funding: none revealed. DHA levels were not recorded in the 2 groups. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly assigned to one of the two groups by balanced blocks using sealed envelopes. Stratification was not included in the block design." Comment: method of random sequence generation not described. |
Allocation concealment (selection bias) | Low risk | Quote: "Randomly assigned to one of the two groups by balanced blocks using sealed envelopes. Group assignment was made by the investigator (last author) who was not involved in the care of the infants." "A member of the TPN team who was blinded and not involved in the care of infants followed orders from the sealed envelope prepared by the investigators." Comment: review authors decided by consensus that the risk was low. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Nurses and doctors responsible for the infants were also blinded to the group assignment." Comment: how the blinding was achieved was not described, therefore the risk was unclear. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All fundus examinations were performed by the same pediatric ophthalmologist who was blinded to the group assignment." Comment: probably done (decision by consensus between review author (VK and MM)). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: follow‐up complete |
Selective reporting (reporting bias) | Low risk | Comment: trial registered with ClinicalTrials.gov under identifier: NCT01875510 and there appeared to be no deviation from the protocol. Study started on 1 January 2013; however, protocol was registered on 31 May 2013. Review authors decided by consensus that the risk was probably low for selective reporting. |
Other bias | Low risk | Comment: none identified |