Rubin 1994.
Study characteristics | ||
Methods | Double blind randomised controlled study done at Beilinson Medical Center, Petach‐Tiqva, Israel. Results regarding fatty acid profile from this study were published in 1995 (Rubin 1995). Enrolment period: not mentioned. I. Allocation Concealment ‐ cannot say II. Blinding of intervention ‐ cannot say III. Blinding of outcome measurement(s) ‐ cannot say IV. Complete follow‐up ‐ no |
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Participants | Preterm infants < 35 weeks who received TPN for ≥ 6 days. A total of 59 infants were enrolled during the study period. | |
Interventions | Preterm infants (initially 59 infants enrolled with 10 withdrawals) who were randomised to receive either: 1) 20% PFE 4501® (soy + borage oil in 8.5:1.5 ratio to increase GLA + added carnitine; n = 16) OR 2) 20% Intralipid® (S‐LE; n = 18) OR 3) 20% Lipofundin MCT® (MS‐LE; LCT from soy: MCT from coconut in 1:1 weight ratio; n = 15) Lipid emulsion: Day 1: 0.5 g/kg/day, day 2: 1.5 g/kg/day to a maximum of 2.5 g/kg/day on day 3, and this dose was maintained until the end of the study period. Co‐interventions with amino acid solution (Vamin) and electrolytes were similar in the two groups. |
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Outcomes | Similar weight gain, clinical variables, acid‐base, blood counts, glucose levels (remained normal) mentioned in all the groups. AST decreased significantly in groups 2 and 3 from baseline, however the values were only provided for triglyceride levels. The fatty acid profile is reported in detail from the same study in Rubin 1995. | |
Notes | Triglycerides levels (mean ± SD) have been reported but authors have not reported the proportion of infants with hypertriglyceridaemia. Therefore we were not able to include any data in the quantitative synthesis for the clinical outcomes. It was a short study of 6 days duration. Authors demonstrated the safety of LE in jaundiced babies as the bilirubin levels fell in both groups despite the rise in free fatty acids as reported in Rubin 1995. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The infant were randomly assigned to..." Comment: No information on random sequence generation provided. |
Allocation concealment (selection bias) | Unclear risk | Comment: No information on allocation concealment was provided. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 10 withdrawals in the study equivalent to 16% of the study sample. Withdrawals were for varying reasons including sepsis (5), hyperbilirubinaemia (1), and thrombocytopenia (2). It is not reported which intervention arm these infants belonged to. Data from these patients is not available. |
Selective reporting (reporting bias) | Unclear risk | Comment: The protocol for the study 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 | Unclear risk | Quote: "randomly assigned in a double blind manner" Comment: How blinding was achieved has not been described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "randomly assigned in a double blind manner" Comment: How blinding was achieved has not been described. |