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. 2018 Jun 8;2018(6):CD012276. doi: 10.1002/14651858.CD012276.pub2

Chiarelli 1996.

Methods RCT, single‐centre, 2‐arm, parallel design
Participants Number of randomized participants: 24
Inclusion criteria
  1. People requiring artificial nutrition and able to use gastrointestinal tract for the purpose


Exclusion criteria
  1. Not reported


Primary diagnosis
  1. Multiple trauma

  2. Guillain‐Barré syndrome

  3. Intracerebral/subarachnoid bleed

  4. Gastric carcinoma

  5. Intestinal carcinoma

  6. Hypoxic coma


Baseline characteristics
EN group
  1. Age, mean (range): 52 (17 to 78) years

  2. Gender: not reported

  3. SAPS II, mean (SD): 10 (± 4)


EN + PN group
  1. Age, mean (range): 49 (18 to 77) years

  2. Gender: not reported

  3. SAPS II, mean (SD): 11 (± 4)


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
  1. Metabolic indices

  2. Incidence of diarrhoea (diagnosed by faecal mass of > 700 g/day)

  3. Nitrogen balance

  4. Infection (measured by blood cultures, chest x‐ray, and bronchoaspirates)

  5. Duration of mechanical ventilation

  6. LOS, mortality (time point not reported)

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