Rubin 1994.
Methods | Design: double‐blind RCT Setting: Beilinson Medical Center, Petach‐Tiqva, Israel Enrolment period: not mentioned. I. Allocation concealment: could not determine II. Blinding of intervention: could not determine III. Blinding of outcome measurement(s): could not determine IV. Complete follow‐up: no |
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Participants | Preterm infants < 35 weeks' gestation who received TPN for ≥ 6 days. 59 infants enrolled, 10 withdrawals | |
Interventions | Group 1 (n = 16): 20% PFE 4501 (soybean + borage oil in 8.5:1.5 ratio to increase GLA + added carnitine); Group 2 (n = 18): S‐LE; 20% Intralipid Group 3 (n = 15): MS‐LE; 20% Lipofundin MCT (LCT from soybean: MCT from coconut in 1:1 weight ratio) LE: 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. Cointerventions with amino acid solution (Vamin) and electrolytes were similar in the 2 groups. |
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Outcomes | Weight gain, clinical variables, acid–base, blood counts, glucose levels (remained normal) mentioned for all the groups. AST decreased significantly in groups 2 and 3 from baseline, however the values were only provided for TG levels. The FA profile was reported in detail from the same study in Rubin 1995. | |
Notes | TG levels (mean ± SD) were reported but authors did not report the proportion of infants with hypertriglyceridaemia. Therefore, we were unable to include data in the quantitative synthesis for the clinical outcomes. Short study of 6 days. Authors demonstrated the safety of LE in jaundiced infants as the bilirubin levels fell in both groups despite the rise in free FAs as reported in Rubin 1995. Results regarding FA profile from this study were published in 1995 (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 provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "randomly assigned in a double blind manner." Comment: blinding not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "randomly assigned in a double blind manner." Comment: blinding not described. |
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 infants is not available. |
Selective reporting (reporting bias) | Unclear risk | Comment: the protocol for the study was not available so we could not ascertain any deviation from the protocol. |
Other bias | Low risk | Comment: none identified. |