Wang 2015.
| Study characteristics | ||
| Methods | Double‐blind, randomised study conducted at NICU of Xin Hua Hospital and Shanghai Children's Medical Center in Shanghai, China. Study enrolment from February 2012 to July 2013. I. Allocation concealment ‐ yes II. Blinding of intervention ‐ yes III. Blinding of outcome measurement(s) ‐ yes IV.Complete follow‐up ‐ yes (per protocol only) |
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| Participants | 118 preterm infants (< 37 weeks) were eligible for inclusion. 103 infants (12 refused consent and 3 died in < 72 hrs before randomisation) were randomised to receive either: 1) S‐LE (Intralipid®; n = 51) 2) OS‐LE (ClinOleic®; n = 52) |
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| Interventions | PN using either S‐LE, n = 51 or OS‐LE, n = 52. | |
| Outcomes | The primary end point was liver chemistry. The secondary end point was plasma bile acid composition. Serum direct bilirubin was reported to be higher after 7 days in the S‐LE group. The study reported on weight gain, days to regain birth weight, duration of ventilation, BPD, NEC, and culture positive sepsis. There were 3 deaths before randomisation and 3 deaths occurred during the study (2 in OS‐LE group and 1 in S‐LE group). ROP, IVH and PVL were not reported in this trial. | |
| Notes | Funding disclosure: Supported in part by grants from the National Natural Science Foundation of China (No. 81100631) and Shanghai Key Laboratory of Pediatric Gastroenterology and Nutrition (No. 11DZ2260500). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "cards were created with a unique randomisation code." Comment: Though the authors did not mention how the unique randomisation code was generated, the review authors agreed that the risk was low |
| Allocation concealment (selection bias) | Low risk | Quote: "...unique randomisation code and placed in sequentially numbered opaque envelopes" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Clinical outcomes were reported for most outcomes. 2 infants in the OS‐LE arm and 2 infant in the S‐LE arm were excluded from analysis as they had < 14 days of parenteral nutrition. Intention to treat analysis was done. |
| Selective reporting (reporting bias) | Low risk | Comment: The study protocol was available: NCT01786759. |
| Other bias | Low risk | Comment: None identified. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Investigators, parents, and all the physicians and nurses involved in patient care were blinded to the group assignment," "The 2 solutions looked identical to the clinicians" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Investigators, parents, and all the physicians and nurses involved in patient care were blinded to the group assignment," "The 2 solutions looked identical to the clinicians" Comment: Reviewers agreed about blinding of outcome assessment. |
ALT: alanine aminotransferase AST: aspartate aminotransferaseROP: retinopathy of prematurity BPD: bronchopulmonary dysplasia BW: birth weight CLD: chronic lung disease DHA: docosahexaenoic acid GGT: gamma‐glutamyl transferase IV: intravenous IVH: intraventricular haemorrhage LCT: long chain triglycerides LE: lipid emulsion(s) MCT: medium chain triglycerides MFS‐LE: medium chain triglycerides‐fish‐soy lipid emulsion MOFS‐LE: medium chain triglycerides‐olive‐fish‐soy lipid emulsion MS‐LE: medium chain triglycerides‐soy lipid emulsion NEC: necrotising enterocolitis NICU: neonatal intensive care unit OS‐LE: olive‐soy lipid emulsion PDA: patent ductus arteriosus PN: parenteral nutrition PVL: periventricular leukomalacia RBC: red blood cells RDS: respiratory distress syndrome S‐LE: soy lipid emulsion TPN: total parenteral nutrition VLBW: very low birth weight