Chiarelli 1996.
Methods | RCT, single‐centre, 2‐arm, parallel design | |
Participants |
Number of randomized participants: 24 Inclusion criteria
Exclusion criteria
Primary diagnosis
Baseline characteristics EN group
EN + PN group
Country: Italy Setting: ICU |
|
Interventions |
EN group n = 12: no apparent losses Details: nutrition initiated 24 to 36 hours after admission. All participants fed with PN for 4 days, then 'weaned' to EN. Nasogastric tube placement, duration of feeding for 7 days, with formula consisting of high protein content with high ratio of calories/nitrogen. Caloric intake received, mean (SD): 33 (± 9) kcal/kg EN with PN group n = 12; no apparent losses Details: nutrition initiated 24 to 36 hours after admission. All participants given PN for 4 days, then given mixed feeding of 50% PN and 50% EN Caloric intake received, mean (SD): 31 (± 6) kcal/kg |
|
Outcomes |
|
|
Notes |
Funding/declarations of interest: not reported Study dates: not reported Study report published in Italian |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants randomly assigned to groups 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) | Unclear risk | No details |
Blinding of outcome assessment (detection bias) Mortality | Low risk | No details. Lack of blinding unlikely to influence outcome data for mortality |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses |
Selective reporting (reporting bias) | Unclear risk | Clinical trial registration or publication of prospective protocol not reported; not feasible to judge risk of reporting bias |
Baseline characteristics | Low risk | Study authors reported that baseline characteristics were comparable |
Other bias | Unclear risk | No other sources of bias identified |