The study was conducted between November 2006 to February 2008 in a prospective and observational manner. The setting was a tertiary care hospital in Delhi, North India. The hospital predominantly caters to poor urban population living in resettlement colonies and slums, and also rural families from neighbouring state of Uttar Pradesh. The study protocol was approved by Institutional Research Board, including ethical clearance. The study procedure was fully explained to the parents/caregivers, and informed written consent was obtained from the primary caregiver.

All consecutive children (6 months to 5 years) with severe malnutrition presenting to the Pediatric out-patient department (OPD) or emergency of hospital were eligible for inclusion. Severe malnutrition was defined as weight for height (or length) <70% of median(2). WHO multicentric growth standards were used as reference criteria(10).

Children were eligible for home management if: (i) mother or caretaker was not full-time employed, (ii) family was residing within 5 km of hospital premises, (iii) mother or caretaker was trainable to provide home-based diet, and (iv) family was financially able to provide the recommended home-based diet. Children having other diseases incriminated as cause of severe malnutrition, including cerebral palsy, congenital heart disorders, hemolytic anemia, malignancies, known metabolic disorders, known malabsorption syndromes, chromosomal malformations, or chronic renal and hepatic disorders, were excluded.

Baseline data collected included demographic details and presence of associated symptoms, including fever, vomiting or diarrhea. Occupation, education and monthly income of parents were recorded and a socio-economic status was assigned based on revised Kuppuswamy classification(11). General hygiene of the household was assessed in terms of source of drinking water, water storage practices, and practice of hand washing. Clinical examination included anthropometry (weight, length, mid-arm circumference, chest circumference and head circumference), general physical examination and systemic examination. The weight was recorded in the nude on an electronic weighing scale (Goldtech, India) to the nearest 5 g. Length was recorded using an infantometer, and head, chest and mid-upper arm circumference were recorded using non-strechable measuring tape using standard techniques(12). The same observer recorded all the measurements. Venous blood was drawn for estimation of hemoglobin, blood sugar, albumin and serum electrolytes. Cultures of the blood, and urine were taken. Chest X-ray and other relevant investigations were done as and when required.

Initial assessment of the patient was done in hospital. Those with complications or loss of appetite were admitted in hospital and managed as per WHO guidelines as adapted by Indian Academy of Pediatrics (IAP)(3). After discharge, they were managed at home using home based diets. Those without complications and with preserved appetite were directly eligible for home-based rehabilitation after initial assessment in hospital.

Initiation of cautious feeding: Feeding was started with starter F-75 made at hospital kitchen using whole milk, sugar, oil and water as per recommended formula(1). As no mineral mix or micronutrient mix was available, potassium, magnesium and zinc were given separately as described above. Initially enough starter was given to provide 100 kcal/kg/day and 1-1.5 g protein/kg/day with 130 mL/kg/day of fluid (when the child had severe edema 100 mL/kg/day was given). Breastfeeding was continued as usual wherever possible. Initially, the child was given feed more frequently with low volume, then gradually frequency of feeds was decreased and volume per feed was increased. As the patient started to regain appetite, the starter feed was changed with home-made food. Mother was counseled to provide type, frequency and quantity of food. Monitoring for amount of feed offered and left over, frequency of vomiting and watery stool were done.

Discharge: Child was considered for discharge when (i) the appetite had returned (easily consuming more than 80% of recommended feeds orally), (ii) child had started gaining weight (gain of at least 5 g/kg/day for 3 consecutive days), (iii) immunization had been initiated, (iv) all acute complications had been treated, (v) micronutrient supplementation was initiated, and (vi) mother had been counseled for home-based care(13).

All children directly enrolled for home-based rehabilitation and those discharged from hospital were eligible for home-based rehabilitation.

Nutritional support: Home based foods were advised to provide 150 kcal/kg/day and 2-3 g/kg/day of proteins. A diet chart was provided using home-based energy dense foods like besan-panjiri, khichdi, parantha enriching them with jaggery and oil. Energy dense feeding was gradually increased so as to provide approximately 150-220 kcal/kg/day and proteins 4-5 g/kg/day. Mother was given advice about type of food, quantity of food, and feeding frequency. No external support for procuring or making food was provided to the families. Daily multivitamin supplement was continued till 16 weeks.

Sensory stimulation and emotional support: Mother was counseled to give tender loving care to the child and to provide cheerful stimulating environment. Child was provided with toys as a part of structured play therapy. Toys like ring on a string, rattle and drum, in and out toy with blocks, posting bottle and doll were given.

Frequency of follow-up visits were: (i) 2 contacts/week separated by at least 48 hours in first two weeks, (ii) once a week for 3-8 weeks, (iii) and from 8 weeks till 16 weeks, every 4 weeks. At each visit, dietary intake was recorded by recall-method, and detailed general physical and systemic examination was done. Mother was recounselled about type, quantity and frequency of food to be given. Any medical problem identified during visits was treated. Measurement of weight, length, head circumference, chest-circumference and mid-arm circumference was done at each visit. Investigations of all children were repeated at 4 weeks and at 16 weeks. The child was stated to have recovered completely if child achieved weight for length >80% at the end of 16 weeks. The child was stated to be partially recovered if the weight for length remained between 70% to 80% after 16 weeks of follow-up. A weight gain of >5g/kg/d was defined as an acceptable weight gain(1,2).

Statistical analysis: Descriptive analysis was carried out for most outcomes. Calorie intake, protein intake, weight and weight-for-height percent at 16 weeks were compared from baseline by paired t test. Data were analyzed using SPSS 12.0 software.

Of 34 patients, 19 were admitted and treated in hospital. The mean (±SD) duration of hospitalization was 5.4 (±2.2) days (median: 6 d; IQR: 4-7 d). Two children had edema during presentation, which settled on day 5 and 8 of admission. Two children died during hospital stay and another 3 children left against medical advice. Thus fourteen children thus were finally discharged. Fifteen children were not hospitalized and sent home after initial assessment in hospital. These 29 children were eligible for home based rehabilitation. Of these, 26 children completed the follow up (Fig.1).

Dietary intake : The mean calorie and protein intake of study subjects who completed 16 weeks follow-up (N=26) at enrolment, day 3, day 7, 3 week, 6 week, 12 week and 16 week is shown in Table II. During the home based management phase, the mean (±SD) calorie intake increased from 100 (±5) kcal/kg/d at enrolment to 243 (±13) kcal/kg/d at 16 weeks (P<0.001). Similarly, protein intake increased from 1.1 (±0.3) g/kg/d to 4.8 (±0.3) g/kg/d (P<0.001).

TABLE II



Changes in Calories and Protein Intake, Weight, and Weight for Length During Follow Up (N=26)

Anthropometry: The mean (±SD) weight (kg) and weight for length (%) of study subjects at enrolment, day 3, day 7, week 3, week 6, week 12 and week 16 is also shown in Table II. Weight gain during hospital stay was 9.0 (±5.3) g/kg/d, while during home-based rehabilitation, average weight gain was 3.2 (±1.5) g/kg/d. During home based rehabilitation, only 3 (11.5%) children achieved weight gain of more than 5 g/kg/d, while 26 (89.5%) children had weight gain of less than 5 g/kg/d.

Three children were lost to follow-up (1 at 3 weeks, and 2 at 4 weeks). However, all these 3 children had crossed the 70% weight for length barrier before opting out of the study, and thus were classified as having partial recovery.

The present study assessed the efficacy of home-based rehabilitation after initial assessment or following discharge from a hospital. We aimed to assess the outcome of home-based management using home-based foods in real life situation as no external monetary support or food was provided during this phase. No home visits were done. Using this strategy, majority of children failed to achieve weight gain of more than 5 g/kg/d; the standard criteria for effectiveness as defined by WHO(1). Also, less than half of children achieved >80% weight for length after follow-up of 16 weeks. The mean weight gain during home based rehabilitation was also less than weight gain during hospital stay.

The mean weight gain in our study (3.2 g/kg/d) was less than that by Gaboulaud, et al. (3) (9.7 g/kg/d), Ashraf, et al. (4) (6 g/kg/d), and Khanum, et al.(7) (4 g/kg/d). Also, the mean duration for achieving weight for length >80% was more in our study in comparison to earlier studies from Bangladesh(4,7). The reasons for early recovery and more weight gain in former studies could be the involvement of salaried health care workers from community in giving proper training and advice. These workers had regular home visits, whereas in our study, home visits during follow-up were not done. Non-availability of ready to use therapeutic food (RUTF) and no external support to the families in form of food or money could be a possible reason of inadequate weight gain in our study. In our patients, weight gain was inadequate during follow-up in most, despite history of consuming adequate calories and proteins from home-based foods. This could be attributed to the poor reliability of dietary recall method as well as lack of a mechanism of monitoring their food preparation and techniques of feeding in our study. It is possible that the foods were not sufficiently energy dense, and the adequate numbers of feedings were not provided due to social constraints. Linear programming analysis of diets from Africa and Bangladesh has suggested that several home prepared diets for severely malnourished children do not achieve the nutrient density required for successful rehabilitation(14). Persistent infections were unlikely as we could not find any such evidence during follow up, and no child on home-based management died.

A potential limitation of our study was that we did not evaluate the outcomes in a comparative manner, and thus the efficacy of the management was not directly compared with hospital care or any other effective approach. The sample size was also small to do any subgroup analysis. The strength of our study was that it was done in realistic scenario without actually providing the food or financial support. This has important operational implications as most facilities managing severely malnourished children in India currently do not provide therapeutic nutrition, and only rely on nutritional advice/counseling.

We conclude that home-based management (directly or following early discharge from hospital) using home prepared food and hospital based follow up is associated with sub-optimal and slow recovery. There should be effective monitoring system and mechanism for providing energy dense foods/ RUTF to strengthen the community based management of severely malnourished children. Effectiveness of community-based rehabilitation may require careful planning and additional resources, including nutrition educators. Provision of RUTF might help in strengthening the implementation process but its cost, logistics of procurement and distribution, sustainability, and consequences of withdrawal would need to be carefully considered. Future research should include comparative evaluation of different strategies in a controlled manner and operational research to strengthen the existing home and hospital based approaches.

Contributors: PG and DS conceptualized and supervised the study. DP and KS collected the data and followed up the patients. DP and KS prepared the initial draft of manuscript which was revised by PG and DS. All authors approved the final manuscript.

Funding: None.

Competing interests: None stated.

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