Author Year

Country

Research Design

PEDro

Sample Size

Methods

Outcomes

Jia, Tong, & Liang (2018)

China

RCT

PEDro = 8

N = 62

Population: Observational Group (N=34): Mean Age=41.5±10.8y; Gender: Male=64.7%, Female= 35.3%; Mean Time Post Injury= within 24 hours; Mean GCS=5.5±1.3. Control group (N=28): Mean Age= 45.4±9.6y Gender: Male=60.7%, Female=39.3%; Mean Time Post Injury= within 24 hours; Mean GCS=6.2±0.7.

Intervention: Both groups received Enteral Nutrition (EN) upon admission. Patients were randomized into 1 of two groups. The observational group was given sequential nutritional support. This was based on a patient’s energy needs and tolerance. Different solutions were used over the course of their first 3 days in treatment, starting with pepsin short peptide type EN moving toward a typical whole protein method. The control group was given standard enteral nutritional formula for their nutrition requirements. Patients were assessed on their first day, 7^th day, and 14^th day.

Outcome measures: Albumin (AP), total protein (TP), high-sensitivity C-reactive protein (Hs-CRP), neuron specific enolase (NSE), Glasgow Coma Score (GCS), and percentage of CD4-CD25 regulatory T cells in peripheral lymphocytes and CD4-CD25-CD127dim T cells in the CD4 lymphocytes.

1.        ALB levels were significantly different between groups on the 14^th day (p<0.05) showing the observational group had higher levels. This was not seen at day 7.

2.        TP levels were significantly different between groups on the 14^th day (p<0.05) showing the observational group had higher levels. Not seen at day 7.

3.        Hs-CRP levels were significantly different between groups on the 7^th and 14^th day (p=0.015 and p=0.047, respectively) showing the observational group had lower levels.

4.        NSE levels were significantly different between groups on the 14^th day (p=0.012) showing the observational group had lower levels. Not seen at day 7.

5.        GCS scores were significantly different between groups on the 14^th day (p<0.05) showing the observational group had higher scores. Not seen at day 7.

6.        CD4-CD25 T cells percentages were significantly different between groups on the 7^th and 14^th days (p<0.05 and p<0.01, respectively) showing the observational group had lower percentages.

7.        CD4-CD25-CD127dim T cells percentages were significantly different between groups on the 7^th and 14^th days (p<0.01) showing the observational group had lower percentages.

Falcao de Arruda and Aguilar-Nascimento (2004)

Brazil

RCT

PEDro=7

N=20

Population: TBI; Treatment Group (n=10): Mean Age=27 yr; Gender: Male=10, Female=0; Mean GCS Score=7. Control Group (n=10): Mean Age=26 yr; Gender: Male=9, Female=1; Mean GCS Score=7.

Intervention: Patients were randomized to receive either the standard diet (control) or the glutamine- and probiotics-enhanced diet (treatment group).

Outcome Measures: Incidence of infection, Length of Stay (LOS) in ICU, ventilation days.

1.        Infection rate was higher in the control than in the treatment group (p=0.03).

2.        LOS (p<0.01), as well as the number of days on ventilation (p=0.04), was significantly higher in the control group compared to the treatment group.

Taylor et al. (1999)

UK

RCT

PEDro=4

N=82

Population: Head Injury. Intervention Group (n=41): Median Age=34 yr. Control Group (n=41): Median Age=28 yr.

Intervention: Patients were randomly allocated to receive either the standard enteral nutrition (EN) or the enhanced EN (intervention). EN was initiated from day 1 in both groups. In the control group, EN was gradually increased from 15 mL/hr up to estimated energy and nitrogen requirements. In the intervention group, feeding was administered at a rate that met estimated energy and nitrogen requirements. Follow-up at 3 and 6 mo.

Outcome Measures: Neurologic outcome, incidence of major infection, Length of stay (LOS).

1.        Patients receiving enhanced EN had a significantly higher mean percentage of energy (p=0.0008) and nitrogen (p<0.0001) requirements met over the initial week following injury when compared to the control group. This finding was mostly attributable to improved NG feeding as only 14 intervention patients (34%) had intestinal tubes successfully placed.

2.        The median percentage of energy and nitrogen requirements delivered in control patients remained <60% even by day 7 post injury.

3.        Neurologic outcome at 6 mo follow-up (intervention, 68% versus control, 61%; p=0.64) was similar between the groups, but there was a trend toward improved outcome at 3 mo follow-up in favour of the intervention group (61% versus 39%; p=0.08).

4.        Intervention patients had fewer infections (61% versus 85%; p=0.02) and earlier discharge (p=0.008).

Painter et al. (2015)

USA

Case Control

N=240

Population: TBI=240; Immune Enhancing Nutrition (IEN; n=126): Mean Age=43.7yr; Mean GSC=6; Standard Formula (SF; n=114): Mean Age=46.7yr; Mean GCS=7.

Intervention: Two groups that received enteral nutrition of either IEN (treatment) or SF (control) were analyzed to determine if immune enhancing nutrients would provide better outcomes.

Outcome Measures: Hospital and ICU Length of Stay (LOS), cultures of blood, urine, and respiratory, temperature, white blood cell (WBC) count, chest X-Ray, nutrition type and measures.

2.        IEN had longer LOS in ICU (p=0.02) and more days on ventilator (p=0.001) than SF, but were less likely to have bacteremia (p<0.05).

3.        No significant difference between IEN and SF in rates of urinary tract infections (p=0.48), Clostridium difficile (p=0.63), and pneumonia (p=0.89).

4.        Similar fungi/bacteria present within both groups.

5.        No significant difference in mortality rates during hospital stay (p=0.88).