Local versus industrially produced therapeutic milks in managing severe malnutrition
By A Ould Sidi Mohamed, M. Diagana, Federica Riccardi, Abimbola Lagunju, Jean-Pierre Papart and Rebecca Norton.
A Ould Sidi Mohamed is a paediatrician and chief of the paediatric ward at the national hospital in Nouakchott, Mauritania.
M Diagana is a paediatrician, responsible for the nutritional unit located in the paediatric ward of the National Hospital.
Federica Riccardi is the Fondation Tdh delegate in Mauritania.
Abimbola Lagunju is the Fondation Tdh Medical advisor for Africa.
Jean-Pierre Papart is the Fondation Tdh Medical advisor, based in Geneva.
Rebecca Norton is Nutrition advisor for IBFAN -GIFA. Previously she worked as Medical advisor with Fondation Tdh.
For the past eight years, Fondation Terre des hommes (Fondation Tdh) have been working in Mauritania, opening a nutritional unit for managing acute malnutrition in 2000. Since 2007, this unit has been fully integrated into the paediatric ward of the Nouakchott National Hospital where children with severe acute malnutrition are managed, with ongoing support from Fondation Tdh. Six to seven years ago, Fondation Tdh operated community centres for case management of malnutrition. However, poor coordination with primary health care (PHC) centres meant that outcomes were often poor. In the past year, Fondation Tdh has focused efforts on strengthening the national nutrition unit and integrating it into the national paediatric facility.
Fondation Tdh has been involved in nutrition projects around the world for many years and has always advocated for a developmental approach to the treatment of severe malnutrition by using local resources. As well as encouraging sustainability, such an approach empowers individuals and communities and strengthens existing government structures, such as Nouakchott National Hospital. In order to strengthen the development of a sustainable strategy for the treatment of severe malnutrition in Mauritania, a study was conducted by Fondation Tdh in 2007/08, to investigate the therapeutic effectiveness of F75 and F100 prepared with ingredients that can largely be locally sourced ('local') versus the industrially produced ('industrial') version. Specifically, the objective of this study was to help the paediatric ward develop a position and policy on the use of therapeutic industrially produced preparations increasingly being promoted by various international agencies.
Patient profile in the National Nutrition Unit
Cooking F75 using flour
Between January 2006 and December 2007, the nutrition unit admitted 487 children (293 boys and 194 girls). The majority of these children were aged between 6 months and 2 years (76.1%), the group at highest risk of malnutrition. Only 2.5% of the children were younger than 6 months and 21.4 % were aged between 2 and 5 years. During the same period, the recovery rate in the nutrition unit improved significantly from 55.6% to 65.7% (p=0.013), while mortality rate decreased from 30.2% to 21.1% (p=0.030). All the children admitted to the nutritional unit in 2006- 2007 were complicated cases of severe malnutrition. Children had generally lost appetite, 13.3% had oedema and the majority had associated medical complications (Table 1). At admission, cases without oedema were very severly wasted, with a mean weight for height z score (WHZ)1 of -4.8 in 2006 and -4.7 in 2007. These all point to children presenting in the latter stages of severe acute malnutrition.
Pooled data for 2006 and 2007 (Table 2) show that mortality rates were particularly high for infants under 6 months of age, although these only comprised a small number of the overall case load and consequently it is not possible to draw conclusions. Data for the same period (Tables 3, 4 and 5) also showed that deaths in the total group did not just occur in the first few days following admission, but well into treatment. While the death rate still remains high, a significant reduction has been achieved in overall mortality compared to the peaks of 30% in 2006, through improvement in the quality of care.
Study Method
Between September 2007 and February 2008, 122 children with severe acute malnutrition admitted to the Specialised Nutrition Unit participated in the randomised study. The trial tested two different therapeutic protocols:
- 'Local' therapeutic milk: F75 and F100 therapeutic milks prepared with dried milk powder, flour (for F75), sugar, oil, water and a mineral complex rich in potassium2 (protocol A)
- 'Industrial' therapeutic milk: Pre-packaged F75 and F100 requiring reconstitution with water only3 (protocol B).
Children were alternately allocated to one of the two arms of the study on arrival in the unit.
Porridge being cooked in the kitchen of the nutrition unit
The 'local' F75 and F100 preparations in protocol A were all based on products that may be sourced in the vicinity, with the exception of the mineral complex (C.M.V Therapeutic) sourced from Nutriset, France. In Mauritania, the milk powder was provided by Fondation Tdh, which was received as a donation from the Swiss government. Protocol B utilised products produced in France.
Preparation of 'local' therapeutic milk is slightly more complicated and the nurses needed to spend some time in the kitchen, while the 'industrial' therapeutic milk simply required mixing powder with measured water. Both preparations need to be refrigerated and used on the day that they are made up. The local ingredients needed for 'local' therapeutic milk are cheaper, with the exception of local F100 made using full cream milk (see Table 6), and their availability is more reliable. Cost and availability were important considerations and motivations for implementing the study.
| Table 1: Associated pathologies at admission | |||
| Pathology | 2006 | 2007 | Significance |
| Fever | 66 (28.0%) | 78 (31.1%) | p = 0.452 |
| Hypothermia | 18 (7.6%) | 11 (4.4%) | p = 0.130 |
| Vomiting | 49 (20.8%) | 114 (45.4%) | p < 0.001 |
| Diarrhoea | 166 (70.3%) | 177 (70.5%) | p = 0.996 |
| Dehydration | 154 (65.3%) | 130 (51.8%) | p = 0.003 |
| Stomatitis | 52 (22.0%) | 59 (23.5%) | p = 0.699 |
| Anaemia | 167 (70.8%) | 132 (52.6%) | p < 0.001 |
| Dermatitis | 25 (10.6%) | 19 (7.6%) | p = 0.245 |
| Urinary infection | 12 (5.1%) | 13 (5.2%) | p = 0.962 |
| Tuberculosis | 14 (5.9%) | 5 (2.0%) | p = 0.025 |
| Otitis | 4 (1.7%) | 6 (2.4%) | p = 0.589 |
| Dysentery | 24 (10.2%) | 25 (10.0%) | p = 0.939 |
| HIV | 12 (5.1%) | 9 (3.6%) | p = 0.416 |
| Malaria | 10 (4.2%) | 8 (3.2%) | p = 0.539 |
| Pneumonia | 18 (7.6%) | 18 (7.2%) | p = 0.848 |
| Meningitis | 0 (0.0%) | 0 (0.0%) | n/a |
Results
Of a total sample of 122 children, 60 received protocol A ('local' therapeutic milk) and 62 received protocol B ('industrial' therapeutic milk). The two groups were comparable in terms of age, sex, clinical symptoms and associated pathologies on admission.
The trial found no statistically significant difference (p=0.702) between the two prescribed protocols in terms of recovery, mortality and defaulting. Furthermore, it was observed that the consumption of 'local' F100 in phase II was better - 86.3% of the prescribed quantity compared to 53.7% of the industrially produced product (Table 7). This difference in acceptability was significant (p<0.001) with the higher consumption level probably explaining (without reaching a level of any statistical significance) the fact that children on Protocol A had a shorter period of hospitalisation (by 24 hours on average) when compared with Protocol B children. Throughout 2007, the overall mean length of stay for children who recovered was 13 days.
On discharge, there was no significant difference in the average weight of the children between the two protocols (protocol A or B) (p=0.896). This applied to both the mean weight-height z score (p=0.665) and average weight gain (p=0.721).
| Table 2: Pooled data for mortality of admissions to the Specialised Nutrition Unit (2006/07) | |||||
| Sex | Age | Total | |||
| < 6 months | 6 - 23 months | 24 - 60 months | |||
| Boys | Survivors | 4 57.1% |
171 77.0% |
46 73.0% |
221 75.7% |
| Died | 3 42.9% |
51 23.0% |
17 27.0% |
71 24.3% |
|
| Total | 7 100.0% |
222 100.0% |
63 100.0% |
292 100.0% |
|
| Girls | Survivors | 2 40.0% |
109 73.6% |
32 78.0% |
143 73.7% |
| Died | 3 60.0% |
39 26.4% |
9 22.0% |
51 26.3% |
|
| Total | 5 100.0% |
148 100.0% |
41 100.0% |
194 100.0% |
|
| Table 3: Time of death (days) from admission (day 0), for boys and girls | ||||
| Sex | Total | |||
| Boys | Girls | |||
| Days before death | 0 -2 days | 24 33.3% |
19 37.3% |
43 35.0% |
| 3-7 days | 26 36.1% |
19 37.3% |
45 36.6% |
|
| > 7 days | 22 30.6% |
13 25.5% |
35 28.5% |
|
| Total | 72 100.0% |
51 100.0% |
123 100.0% |
|
P=0.841
| Table 4: Time of death (days) from admission (day 0), 2006 versus 2007 | ||||
| Year | Total | |||
| 2006 | 2007 | |||
| Days before death | 0 -2 days | 23 32.9% |
20 37.7% |
43 35.0% |
| 3-7 days | 26 37.1% |
19 35.8% |
45 36.6% |
|
| > 7 days | 21 30.0% |
14 26.4% |
35 28.5% |
|
| Total | 70 100.0% |
53 100.0% |
123 100.0% |
|
P=0.837
| Table 5: Time of death (days) from admission by (day 0), age-group (2006/2007) | |||||
| Age | Total | ||||
| < 6 months | 6 - 23 months | 24 - 60 months | |||
| Days before death | 0 -2 days | 2 33.3% |
33 36.7% |
7 26.9% |
42 34.4% |
| 3-7 days | 4 66.7% |
36 40.0% |
5 19.2% |
45 36.9% |
|
| > 7 days | 0 |
21 23.3% |
14 53.8% |
35 28.7% |
|
| Total | 6 100.0% |
90 100.0% |
26 100.0% |
12 100.0% |
|
P=0.012
| Table 6: Costs for 'local' versus 'industrial' therapeutic milks (excluding transport costs) | ||||
| Cost of 'local' therapeutic milk | Cost of 'industrial' therapeutic milk | |||
| Excluding milk powder cost* | Including milk powder cost* | |||
| F100 prepared with skimmed milk | 0.31 euro/litre | 0.60 euro/litre | F100 | 0.56 euro/litre |
| F100 prepared with full cream milk | 0.17 euro/litre | 0.72 euro/litre | ||
| F75 prepared with skimmed milk | 0.19 euro/litre | 0.28 euro/litre | F75 | 0.53 euro/litre |
| F75 prepared with full cream milk | 0.15 euro/litre | 0.33 euro/litre | ||
* In Mauritania, Fondation Tdh uses donated milk powder from the Swiss government to prepared 'local' RUTF
** A cost for milk powder is included here based on the Swiss official price for dried milk.
| Table 7: Consumption of 'local' therapeutic milk versus 'industrial' F100 in Phase 2 | |||
| Consumption of F100 | |||
| <80% prescribed amount % (n) | >80% prescribed amount % (n) | Total % (n) | |
| 'Local' therapeutic milk | 13.7% (7) | 86.3% (44) | 100% (51) |
| 'Industrial' therapeutic milk | 46.3% (25) | 53.7% (29) | 100% (54) |
| Total | 30.5% (32) | 69.5% (73) | 100% (105) |
Conclusions and discussion
Staff with registers of the amount of F75/F100 actually drank by the children
Industrially prepared F75 and F100 formulas did not demonstrate any advantage over locally produced formulas with added mineral-vitamin complex, in the management and outcome of acute severe malnutrition. In addition, the 'local' F100 seemed better accepted by the children. The paediatric ward is still in the process of reviewing whether to use 'local' versus 'industrial' therapeutic products.
In 2009, Fondation Tdh plans to implement community activities and support PHC centres in the administrative wards of Nouakchott where there is endemic severe wasting. It is hoped that this will facilitate earlier treatment of malnutrition (in the community) and lead to a reduction of cases presenting with severe complications at the special nutrition unit in the paediatric ward of Nouakchott Hospital.
Fondation Tdh has strong reasons, stemming from our understanding of sustainable development and human rights approach, to argue for maintaining the use of locally made therapeutic milk with added micronutrients (CMV). Not only do locally sourced formulations reduce the dependency on imported ready-formulated products and are therefore more sustainable, but they also ensure that kitchens are maintained in the hospitals. Kitchens are important for social interaction between caregivers and hospital staff. They are also essential for teaching caregivers practical skills to support optimal infant and young child nutrition, for example the preparation of porridges used in phase 2 of treatment of acute severe malnutrition. With complete dependency on industrially produced products, kitchens will disappear and staff will no longer have the skills and experience for carefully preparing locally made versions. With such short sighted strategy, malnourished children also risk being the victims of any breakdown in the supply chain of imported products.
Using local skills and products for the treatment of severe acute malnutrition as much as possible empowers local communities and offers them sustainable solutions, rather than creating a dependency on external, medical 'technical fixes'. Moreover, in the era when concerns over the ecological future of the planet must no longer be overlooked, locally produced milk offers a practice that is generating far less waste in the form of packaging.
An approach firmly embedded in broader understanding of sustainable development and human rights is important in the face of a changing world in which technology is too often portrayed as the 'one fits all' solution to all the problems. Fondation Tdh would very much welcome a debate about these key issues.
For further information, contact: Jean-Pierre Papart, email: jeanpierre.papart@tdh.ch
1A Weight for height z score of less than -3 SD is used as admission criteria.
2CMV Therapeutic, sourced from Nutriset, France
3Produced by Nutriset, France
Imported from FEX website