Vlaardingerbroek 2014.
Study characteristics | ||
Methods | Randomised prospective single centre study in VLBW preterm infants conducted at NICU of the Erasmus MC‐Sophia Children’s Hospital, Rotterdam, The Netherlands. Study enrolment: December 2008 to January 2012. I. Allocation concealment ‐ yes II. Blinding of intervention ‐ cannot tell III. Blinding of outcome measurement(s) ‐ cannot tell IV. Complete follow‐up ‐ yes (per protocol only) |
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Participants | Inclusion criteria: Inborn VLBW infants (birth weight < 1500 g) with a central venous catheter for clinical purposes were eligible for the study. Exclusion criteria: Congenital anomalies, chromosome defects, metabolic diseases, and endocrine, renal, or hepatic disorders. |
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Interventions | Ninety‐eight preterm infants were randomised to receive either: 1) MOFS‐LE: (n = 49; SMOFlipid® 20%, Fresenius Kabi, Germany) 2) S‐LE: (n = 49; Intralipid® 20%, Fresenius Kabi, Germany) There was one withdrawal from each arm (leaving 48 infants in each arm). |
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Outcomes | Primary outcomes were fatty acid concentration in plasma triglycerides and phospholipids. Secondary outcomes included hematological, biochemical parameters, phytosterol concentrations, and clinical outcomes including survival, duration of hospital stay, symptomatic PDA, RDS, BPD, NEC, late‐onset sepsis, IVH, PVL, ROP and cholestasis. Growth outcomes were reported as a part of efficacy parameters. | |
Notes | Funding source: None disclosed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer generated block randomisation list with variable block sizes generated by a statistician" |
Allocation concealment (selection bias) | Low risk | Quote: "sealed opaque randomisation envelope that was stratified by weight (< 1000 g and 1000–1499 g) and sex. The envelopes were made by a research pharmacist who was not involved in clinical care" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Clinical outcomes were reported for most infants. |
Selective reporting (reporting bias) | Low risk | Comment: The study protocol was available at www.trialregister.nl.com, registration no. NTR1445 |
Other bias | Low risk | Comment: None identified. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "randomisation to the lipid group remained double‐blinded throughout the study and the analyses;" "double‐blind randomised controlled trial." Comment: Details of how blinding was achieved were not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "randomisation to the lipid group remained double‐blinded throughout the study and the analyses;" "double‐blind randomised controlled trial." Comment: Details of how blinding was achieved were not described. |