The WHO protocol for the management of severe malnutrition has some limitations. In this protocol, there are phases of feeding from low to high calorie density. Treatment includes dose of a combined mineral and vitamin mix (CMV), which is difficult to procure locally. Whereas, ICMH protocol is locally adapted and easy to follow. The calorie density is same through-out and micronutrient deficiency is corrected using locally available minerals and vitamins.

This study was conducted to compare the outcome of management of severe malnutrition in children by ICMH protocol with the WHO protocol. Our study was based on the hypothesis that a similar outcome can be achieved by modifying the WHO protocol, by providing fixed calorie diet and replacing CMV with locally available vitamins and minerals.

This quasi-experimental clinical trial was conducted in two hospitals for six months from June to December 2003. One hospital each used the WHO protocol and ICMH protocol for treating severely malnourished children(4,5). The sample size for equivalence was calculated assuming that the mean time taken for targeted weight gain is 25 days in each group with SD of 6 days. Minimum acceptable difference in the two groups was 4.5 days with alpha error 0.05, and power 80%.

Severely malnourished children, aged 2 months to 59 months, whose weight for height was below 70% of the expected (NCHS/WHO references)(6), with or without bilateral pitting edema were included in the study. Children with major congenital abnormalities or disabilities and having feeding difficulty were excluded. All children belonged to the urban and periurban areas of Dhaka. Children at Ad-din Hospital, Dhaka (Group I, n=30) were managed according to WHO Protocol(4). Children at ICMH, Dhaka (Group II, n=30) were managed by ICMH Protocol(5). Senior staff nurses and doctors of each hospital were trained on the specific management protocol. Senior staff nurses were involved for supervised feeding and monitoring of children, and in helping the physician during anthropometric measurements. Study children were assessed by history, anthropometry, clinical examination and laboratory investigations and managed as per specified protocols. Permission from the ethical committee was obtained and, an informed consent was obtained from the child’s guardian before including the child in the study.

Group I: WHO protocol: The management of children with severe malnutrition was divided into 2 phases; initial, and rehabilitation phase and managed as per the protocol(4).

Group II: ICMH protocol(6): In this protocol, there was no phasing in the management. Identification of life-threatening problems, and management of unconsciousness, convulsion, hypothermia, and hypoglycaemia were done as for Group I. Correction of electrolyte imbalance and micronutrients deficiencies were done by giving locally available minerals and trace elements like Potassium chloride (5 mmol/kg/day), Magnesium sulphate (10 mg/kg/day), Zinc sulphate (2 mg/kg/day), Folic acid (2.5 mg/day), and multivitamins 0.6 mL/day (com-position per 0.6 mL of multivitamin: vitamin D1, 200 i.u., thiamine 1 mg, riboflavin 1 mg, pyridoxine 1mg, panthenol 2mg, nicotinamide 5mg, vitamin C 60 mg) orally. Copper was not available in the local market for use. Iron supplementation (6 mg/kg/day) was started on the 15th day. In case of severe anemia with or without heart failure, blood transfusion was given. Every child was given vitamin A supplement. Antibiotics used in this protocol were the same as recommended by WHO. Feeds were made using whole cow’s milk, sugar, soya oil and water to provide 100 kcal in 100 mL/kg/day administered every 2 hours during day and night. If the child wanted more than the prescribed diet, extra family food was given ad-libitum and breastfeeding was encouraged. Play therapy, nutrition education, and discharge criteria were similar to those for children in Group I.

Statistical analysis: All the clinical parameters, appetite, weight, edema etc. were collected daily. Data were collected through structured questionnaire and checked manually at collection period and prior to entry into computer program. MS Access was used for data entry and SPSS/PC+ for analysis. For comparing the continuous variables like mean weight gain, mean duration of gaining target weight among two groups, student’s t test was used, and for comparing the mortality rate, chi- square test was used.

The baseline characteristics of the two groups were similar (Table I). Two third children were marasmic and one third had edematous malnutrition. Table II compares outcome variables between the two groups, which were found to be comparable.

Table I



Sociodemographic Characteristics and Nutritional Status of Children by Study Group

The growth rate varied depending upon the age of the child. In Group I, mean weight gain (SD) was 11.6 (6.8), 12.3 (4.7), 11.4 (3.1) and 11.1 (2.4) gram per kg per day for the 0-6 months, 7-12 months, 13-24 months and above 2 years patients, respectively. On the other hand, it was 17.5 (7.5), 11.8 (2.4), 11.2 (11.2) and 8.1 (2.6) gram per kg per day for the 0-6 months, 7-12 months, 13-24 months and above 2 years patients, respectively in Group II. The difference between two groups were not statistically significant. The average time for improvement of appetite was 7.3 (2.7) days and 7.9 (2.2) days in Group I and Group II, respectively, the difference was not statistically significant.

Table II



Comparison of the Outcome Variables Between the Two Groups

For the management of severe malnutrition in the hospital setting using the WHO protocol, the gradation of hypo-to isocaloric feeds and the use of specific vitamin mineral mix may not be feasible, especially in developing countries. For the manage-ment of malnourished children, the protocol developed by ICMH differs from that of WHO. In the ICMH protocol; (i) the child was fed with fixed caloric diet, 100 Kcal/kg per day from the beginning of management and continued throughout hospitali-zation; (ii) vitamins and minerals were not mixed with the diet; and (iii) potassium, zinc, magnesium and multivitamins were given separately. The present study result has shown that local adaptation of the protocol can yield comparable result.

The study is unique in the sense that it has documented comparisons of treatment outcome in terms of specific indicators like time needed for gaining target weight, weight gain in grams per kg per day and mortality. Though the sample size seems small, the power calculation is enough for the time to achieve target weight gain. For mortality, this sample size may not be adequate. Again the study groups were not taken from same hospital. This could lead to some selection bias.

If the feasibility of implementation of local protocols is considered, there was no change of diet from F-75 to F-100 in ICMH protocol; rather, same calorie-dense food (100 kcal/100mL) was provided throughout the whole length of stay in hospital. Locally available cow’s milk, zinc, potassium, magnesium sulphate and multivitamins were used in ICMH protocol instead of imported skimmed milk and CMV. Standard ORS was used instead of CMV based ReSoMal to correct dehydration. Though acceptance was not specifically studied, the service providers appreciated the simplicity of ICMH protocol. Although the cost involved in managing severely malnourished children was not calculated methodically, it is presumed that because ICMH protocol depended on locally available products and duration of hospital stay was almost same, the cost would be lower in case of ICMH protocol.

The result obtained in this study has important implications in introducing protocol based manage-ment of severely malnourished children in hospitals with limited resources. ICMH protocol appears to be a feasible alternative in district hospitals of developing countries for management of severe malnutrition.

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