Summary of findings 6. Fish oil lipid emulsion (LE) compared to non‐fish oil LE for parenterally fed preterm infants with cholestasis.
| Fish oil LE compared to non‐fish oil LE for parenterally fed preterm infants with cholestasis | ||||||
| Patient or population: parenterally fed preterm infants with cholestasis Setting: NICU Intervention: fish oil LE Comparison: non‐fish oil LE | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with non‐fish oil LE | Risk with fish oil LE | |||||
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Resolution of PNALD/ cholestasis (conjugated bilirubin < 2 mg/dL) Pure F‐LE vs Intralipid Follow‐up: mean 2–4 months |
Study population | RR 5.6 (0.34 to 93.35) | 16 (1 study) | ⊕⊝⊝⊝ Very lowa,b,c,e | Fish oil LE likely reduced resolution of PNALD/ cholestasis. This used 10% Intralipid. | |
| 0 per 1000 (baseline rate) | 0 per 1000 | |||||
| 50 per 1000 (if 5% of infants with cholestasis improve with non‐fish LE) | 280 per 1000 improved with fish oil emulsion (17 to 1000) | |||||
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PNALD/ cholestasis (any definition) MOFS‐LE vs S‐LE Pure F‐LE vs S‐LE Follow‐up: mean 2–4 months |
Study population | RR 0.54 (0.32 to 0.91) | 40 (2 studies) | ⊕⊝⊝⊝ Very lowb,c,d | Fish oil LE may have reduced PNALD/ cholestasis – MOFS‐LE vs S‐LE. 1 trial was stopped after interim analysis. 1 trial used 10% Intralipid. |
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800 per 1000 continued to have cholestasis (80% rate in non‐fish oil LE) |
432 per 1000 had cholestasis (256 to 728) |
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Growth rate Pure F‐LE vs S‐LE |
The mean weight gain 0 g/week |
MD 45 g/week higher (15.00 higher to 75.00 higher) | — | 16 (1 study) | ⊕⊝⊝⊝ Very lowb,c,e | — |
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Head growth velocity Pure F‐LE vs S‐LE |
The mean head growth velocity was 0 cm/week |
MD 0.16 cm/week higher (0.01 lower to 0.33 higher) | — | 16 (1 study) | ⊕⊝⊝⊝ Very low,a,b,c,e | — |
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Death before discharge – MOFS‐LE vs S‐LE – Pure F‐LE vs IL |
Study population | RR 0.24 (0.03 to 1.87) | 40 (2 studies) | ⊕⊝⊝⊝ Very lowa,b,c | — | |
| 150 per 1000 | 36 per 1000 (4 to 280) | |||||
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Any sepsis – MOFS‐LE vs S‐LE – Pure F‐LE vs IL |
Study population | RR 1.21 (0.5 to 2.92) | 40 (2 studies) | ⊕⊝⊝⊝ Very lowa,b,c | — | |
| 300 per 1000 | 363 per 1000 (150 to 876) | |||||
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Conjugated bilirubin levels – MOFS‐LE vs S‐LE |
The mean conjugated bilirubin levels was 0 μmol/L | MD 47 µmol/L lower (71.65 lower to 22.35 lower) | — | 24 (1 study) | ⊕⊕⊝⊝ Lowb,e | Authors excluded 1 infant with sepsis‐related increase in conjugated bilirubin in their analysis. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; F‐LE: fish oil lipid emulsion; LE: lipid emulsion; MOFS‐LE: medium‐chain triglycerides (MCT)‐olive‐fish‐soybean oil‐lipid emulsion; PNALD: parenteral nutrition‐associated liver disease; RR: risk ratio; S‐LE: soybean oil‐based lipid emulsion. | ||||||
| GRADE Working Group Grades of Evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded by one level as the effect size confidence intervals include null effect and RR of 0.75 or 1.25 (or limit of appreciable benefit or harm for continuous outcomes). bDowngraded by one level as the optimal information size is not reached. cTrial stopped prior to full completion. Evidence was downgraded by one level where this trial contributed > 20% or was the only contributor to evidence.
dDowngraded by one level as the two studies in this outcome used different cut‐offs for conjugated bilirubin. eThe evidence would be further downgraded by one level for this outcome as it was a single small study. This downgrading would not apply if this was a large randomised study.