CLINICAL TRIALS OF AN INSTANT TUBE-FEEDING FORMULA IN ENTERALLY FED PATIENTS IN HOSPITAL SETTING

Transcription

1 CLINICAL TRIALS OF AN INSTANT TUBEFEEDING FORMULA IN ENTERALLY FED PATIENTS IN HOSPITAL SETTING CELESTE C. TANCHOCO, Sci. III Food and Nutrition Research Institute Department of Science and Technology

2 OBJECTIVES

3 Specific Objectives Specific Objectives To assess nutritional status of patients being fed with instant tubefeeding formula To determine biochemical and metabolic indices in patients being fed with tubefeeding formula To evaluate diet tolerance to the formula To assess the bacteriological safety of the formula

4 METHODOLOGY

5 Subjects 14 adult: 11 males, 3 females age range: 1771 years old confined at Sto. Tomas University Hospital, Clinical Division, from April 8 to June 17, 1997 Prerequisite for inclusion criteria Informed consent Inclusion Criteria Patient required tube feeding with calorie density of 1 kcal/ml No other dietary modification Could not or would not be fed by mouth

6 Parameters Blood examination hemoglobin, hematocrit, FBS, BUN, albumin and serum electrolytes Anthropometric measurements Weight, skin fold thickness, midupper arm circumference Nutrient intake and % adequacy Microbiological examination of formula, after preparation before first feeding and before last feeding: TPC, E. coli, yeasts, molds Subjective Evaluation

7 Feeding Prescription Day kcal/ml, ml x 6 feeding Day kcal/ml, ml x 8 feeding Day 4 14 kcal/ml, ml x 8 feeding Bolus feeding via size 16 nasogastric tube TER based on HarrisBenedict equation Protein requirement = 1.1 g/kg % adequacy = Nutrient Intake X 100 Nutrient RDA

8 Statistical Analyses Statistical Analyses Descriptive statistics ANOVA test

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10 Table 2. General Profile of 14 Subjects Given Experimental Enteralfeeding Formula, STUH, 1997 Classification Mean age (yrs) Mean weight (kg) Mean mid upper arm circumference (MUAC) (cm) Mean triceps skin fold (TSF) (mm) Mean scapula skin fold (SSF) (mm) Body Mass Index (BMI) (W/H 2 ), normal = Diagnosis Cancer (n=8) Mandibular fracture (n=3) Vehicular accident (n=1) Muscular dystrophy (n=1) Cerebral infarct (n=1) Mean

11 Mean Energy Intake, Energy Prescription TER Parameters Volume intake Energy intake Energy prescription % adequacy intake vs. R x Total energy requirement % adequacy intake vs. TER 1614 ml 1617 kcal 1750 kcal kcal 64.1

12 kcal Intake Prescription TER Figure 1. Comparison of Energy Intake, Prescription and Requirement

13 Table 3. Change in Anthropometric Measurements of 14 Subjects Given Experimental Feeding Formula Anthropometric measurements Weight (kg) MUAC (cm) TSF (mm) SSF (mm) BMI (kg/m 2 ) Change 1.8 ns 1.6 ns 0.7 ns 0.4 ns 0.7 ns

14 Table 4. Mean Nutrient Intake and Percentage (%) Adequacy Nutrient Mean Intake % Adequacy Protein (gm) Calcium (mg) Iron (mg) Vit. A (RE) Thiamin (mg) Riboflavin (mg) Preformed Niacin (mg) Ascorbic Acid (mg)

15 Table 5. Blood chemistry profile of 14 subjects given experimental feeding formula, STUH, 1997 Variables Total Subjects Phases of Feeding Initial Final Mean ± S.D. Mean ± S.D. Hemoglobin (g/l) Hematocrit (g/dl) FBS (mmol/l) BUN (mmol/l) Albumin (g/dl) Sodium (mmol/l) Potassium (mmol/l) Chloride (mmol/l) Calcium (mmol/l) Phosphorous (mmol/l) Magnesium (mmol/l)

16 Table 6. Results of microbiological analysis of 13 enteral tube formula stored at room temperature Storage Time Total Plate Count Coliform Ecoli Yeasts & Molds 1 st month of storage 3x10 4 col/g 5x10 3 col/g 1x10 3 col/g 2 nd month of storage 2x10 4 col/g 6x10 3 col/g 5x10 3 col/g 3 rd month of storage 2x10 4 col/g 2x10 3 col/g 2x10 3 col/g 4 th month of storage 1x10 3 col/g 2x10 3 col/g 2x10 3 col/g 2x10 3 col/g 5 th month of storage 1x10 4 col/g 12x10 3 col/g 4x10 3 col/g 6 th month of storage 3x10 4 col/g 5x10 3 col/g 8x10 2 col/g

17 Table 7. Percentage distribution of subjects according to overall assessment after intervention Patient s Physician s Overall Assessment Assessment Assessment No. % No. % Very satisfactory Satisfactory Fair Poor No assessment

18 CONCLUSION Results of the study suggest that for a short period of time, at least, the tubefeeding formula developed by the FNRI can prevent nutritional deterioration. Despite high microbiological susceptibility of the formula, no untoward symptoms of bacterial contamination were noted. The formula was well tolerated as confirmed by the positive subjective evaluation of both patients and physicians.

19 RECOMMENDATIONS Supplementation of the formula with niacin and ascorbic acid Assurance of acceptable bacteriological limits of the formula must be undertaken. Improvement of technology to reduce viscosity.

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