Dunham 1994.
Methods | RCT, single‐centre, 3‐arm, parallel design | |
Participants |
Total number of randomized participants: 38 Inclusion criteria
Excluded criteria
Primary diagnoses
Baseline characteristics EN group
PN group
EN + PN group
Country: USA Setting: trauma centre |
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Interventions |
EN group n = 12; 0 losses Details: transpyloric tube placement, feeding started within 24 hours of randomization and continued for 7 days. Investigators used Harris Benedict formula BEE x 1.3 to calculate caloric intake. Aimed to provide 50% projected calories by 24 hours after randomization; and 100% by 48 hours. Formula was Traumacal (Mead‐Johnson), NPC given in form of lipids (30%) and carbohydrates (70%). Ratio of NPC to nitrogen was 105:1. Protein load was 1.75 g/kg/day. Mean caloric intake: 1789 calories/day for 7 days PN group n = 16; 1 participant died on 4th study day, not included in study analysis but we have included in review outcome data. Details: feeding started within 24 hours of randomization and continued for 7 days. Investigators used Harris Benedict formula BEE x 1.3 to calculate caloric intake. Aim to provide 50% projected calories by 24 hours after randomization; and 100% by 48 hours. Formula consisted of dextrose‐lipid‐AA mixture; soybean solution, multi‐vitamin mixture. Mixture was 6.7% AA and 23.1% dextrose, soybean solution provided 30% of the NPC. Mean caloric intake: 1961 calories/day for 7 days EN + PN group n = 10; 0 losses Details: feeding started within 24 hours of randomization and continued for 7 days. Investigators used Harris Benedict formula BEE x 1.3 to calculate caloric intake. Aim to provide 50% projected calories by 24 hours after randomization; and 100% by 48 hours. EN formula provided 50% of calories and PN formula provided 50% of calories. EN consisted of Traumacal (Mead‐Johnson), NPC given in form of lipids (30%) and carbohydrates (70%). PN formula consisted of dextrose‐lipid‐AA mixture; soybean solution, multi‐vitamin mixture. Mean caloric intake: 2030 calories/day for 7 days |
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Outcomes |
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Notes |
Funding/declarations of interest: not reported Study dates: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomized but no additional details |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No details and we assumed investigators made no attempts to blind personnel |
Blinding of outcome assessment (detection bias) All outcomes (except mortality) | Low risk | Most outcome data were taken from the trauma registry. Quote: "All data from the trauma registry and the finance officers were blinded, since these sources had no knowledge of the patient's status relative to the research arm assigned." |
Blinding of outcome assessment (detection bias) Mortality | Low risk | Outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 participant was not included in data for PN group due to death during 7‐day intervention period; we have included this event in review analysis. No other loss of data |
Selective reporting (reporting bias) | Unclear risk | Clinical trials registration or prospectively published protocol not reported; not feasible to judge risk of selective outcome reporting bias |
Baseline characteristics | Low risk | Some usual baseline characteristics not reported (age, gender) but other characteristics all appeared comparable |
Other bias | Unclear risk | Target rate of nutrition the same. Unclear if differences in formula were equivalent |