2007 RUTF 2006 UNITAID MOU

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1 Protocol for the Initial Demonstration of Plumpy nut: Introducing Ready-to-Use Therapeutic Food (RUTF) as a Food Supplement for Treating Severe Acute Malnutrition (SAM) in Children in Cambodia 1. Background Pediatric acute malnutrition is a problem across Cambodia, especially in rural areas that suffer from grave food insecurity. Severe acute malnutrition (SAM) is a severe reduction in weightfor-height (wasting) due to a short-term nutritional deficit. Children may suffer from SAM when nutrient intake is insufficient to meet normal physiological needs, or when an underlying disease process increases the metabolic demands on the body, decreases food intake, or both. Severe acute malnutrition and HIV often go hand in hand. Many HIV+ children become acutely malnourished because HIV induces a hyper-metabolic state. Addressing SAM can improve a child s overall health status and can improve disease outcomes. ARV treatment is markedly improved in HIV+ children who are properly nourished. Ready-to-Use Therapeutic Food (RUTF), an energy-dense lipid paste supplement enriched with vitamins and minerals, has made it easier than ever to treat SAM by opening up the possibility of Outpatient care to those children who exhibit SAM, but who do not exhibit other complications. The first RUTF, Plumpy nut, is a peanut-based paste produced by the French company Nutriset. Plumpy nut is nutritionally similar in formulation to Formula 100 (F100), the current WHO recommended product to treat SAM. RUTF has received global approval from UNICEF, WHO, WFP and SCN (Joint Statement, March 2007). Furthermore, Nutriset has UNICEF certification for good manufacturing practices for Plumpy nut. Globally, RUTF is currently utilized as a treatment for malnutrition by the World Food Programme (WFP), Medicins Sans Frontieres (MSF) and other organizations. MSF- France recently began the first Plumpy nut pilot program in Cambodia to treat SAM adults. Angkor Hospital for Children in Siem Reap currently utilizes Plumpy nut for treating SAM in children in both Inpatient and Outpatient care settings. Recent studies have shown that Outpatient care and treatment for SAM using RUTF promotes faster recovery than Inpatient care and treatment using F100 (Diop et al 2003; Sandige et al 2004; Ciliberto et al 2005). In addition, Plumpy nut is oil-based with low water activity and, as such, can be stored and administered at home with little risk of microbial contamination (Briend 2002). It requires no mixing, diluting or cooking, can be eaten straight from the packet, and can have up to a 24-month shelf life from the date of production. Neither Plumpy nut nor any other RUTF is currently used in Cambodia as food supplementation for treating severe acute malnutrition in children. Rather, standard treatment consists of F100 1

2 formula, and all ingredients for F100 formula are mixed on-site at nutrition wards in Referral Hospitals. Thus, treating SAM is currently limited only to Inpatient care. The Clinton Foundation HIV/AIDS Initiative (CHAI) seeks to promote RUTF as a more efficacious and cost-effective alternative to F100, while supporting Cambodia s overall National strategy for the care and treatment of malnourished children. In fact, currently the costs of the food components of RUTF and F-100 are similar, about $3/kg (Ciliberto et al 2005). CHAI s Nutrition Access Team is working at a global level to lower the cost of RUTF. The overall 2007 RUTF donation was included in the December 2006 UNITAID MOU signed between Prime Minister Hun Sen and President Bill Clinton, which authorized the importation of Plumpy nut and guaranteed its distribution to patients free of charge. As such, the current Plumpy nut donation is FULLY funded by UNITAID. In organizing the initial demonstration of Plumpy nut, CHAI has collaborated with the following government and partner organizations: National Center for HIV/AIDS, Dermatology, and STI Control (NCHADS) National Nutrition Programme (NNP) of the National Maternal and Child Health Center (NMCHC) Infant and Young Child Feeding Technical Working Group Center for Communicable Diseases (CDC) of the Ministry of Health (MOH) National Pediatric Hospital (NPH) WHO UNICEF MAGNA TASK French Red Cross New Hope for Cambodian Children (NHCC) The current Plumpy nut donation will target HIV+ children exhibiting SAM without complications. HIV- children as well as those of unknown HIV status who exhibit SAM without complications are also eligible to receive Plumpy nut. Plumpy nut will be used will be used primarily for Outpatient Therapeutic Care (OTC), initiated and monitored in a hospital setting. It will also be available as a replacement for F100 in Inpatient care where applicable. In addition, referral mechanisms to HIV testing and counseling will be strengthened. Linkages should also be strengthened between the treatment of SAM and feeding counseling on good nutrition and food preparation. In all settings, Plumpy nut will be provided as a food supplement for treating SAM, not as ongoing nutritional support. 2

3 2. Desired Goals for the Initial Demonstration of Plumpy nut To introduce RUTF to Cambodia s National Healthcare System To treat HIV+ and HIV- SAM children To improve the nutritional status of HIV+ SAM children, thereby delaying the onset of ARV treatment and improving treatment outcomes To introduce Outpatient care for treating SAM without complications in children To determine the acceptability and effectiveness of RUTF in Cambodia To strengthen referral mechanisms from malnutrition wards to HIV testing To understand and fine tune logistical implementation of RUTF To determine if OTC is a viable alternative to Inpatient care for treating children exhibiting SAM without complications To understand whether RUTF can be implemented as a efficacious, sustainable, and costeffective food supplement for treating SAM on a national level 3. Protocol for the Initial demonstration of Plumpy nut 3.1 Selection of Locations for Initial Demonstration Sites to be selected for the initial demonstration of Plumpy nut must meet the following criteria: The site provides or is closely connected to care and treatment for pediatric HIV/AIDS and malnutrition Strong pre-existing relationships exist with partner organizations at the site A network of home based care (HBC) is connected to the site Initial Sites for the Plumpy nut Demonstration (HBC teams in parentheses): National Pediatric Hospital (French Red Cross) Chea Chumneas Referral Hospital in Takhmao (MAGNA) Svay Rieng Referral Hospital (UNICEF) TASK Clinic (TASK) Secondary Batch of Sites for the Plumpy nut Demonstration Sihanoukville Referral Hospital (French Red Cross) Kampong Cham Referral Hospital (UNICEF, MSF-France) Takeo Referral Hospital? Battambang Referral Hospital? Others At each initial site, there will be extensive collaboration among government health professionals, partners providing technical assistance, and partners directly involved in implementation. Many sites in Cambodia meet the criteria for implementation listed above. Plumpy nut can be rapidly expanded to additional sites should it prove to be an acceptable and effective in treating SAM children in Cambodia. Additional sites will be chosen in coordination and agreement with NCHADS and the National Nutrition Programme of NMCHC. 3

4 3.2 Training Public and NGO partners have worked together to develop an RUTF training curriculum for doctors, nurses and counselors. This curriculum is based on successful implementation programs using RUTF in other countries, but it has been tailored to the specific needs and culture of Cambodia. Two initial half-day trainings on SAM and Plumpy nut will be held one for doctors and the other for nurses and counselors. The first two trainings will be supported by CHAI and NPH and will be administered by NPH, Chea Chumneas RH, and MAGNA. These sessions will train all health professionals involved in the initial demonstration on the following: Clinical diagnosis of SAM Entrance criteria for Outpatient Therapeutic Care Proper dosing and administration of Plumpy nut Counseling for caregivers so that their children will properly take the Plumpy nut and adhere to the Plumpy nut regimen Safety protocol for Plumpy nut Monitoring forms Discharge criteria 3.3 Development of IEC Materials Plumpy nut implementation partners have worked together to create IEC materials targeted towards caregivers of SAM children. These materials contain sensitization messages on the proper dosing and administration of Plumpy nut. 3.4 Eligibility Criteria for Plumpy nut in Outpatient Therapeutic Care Children presenting at a facility providing Outpatient Therapeutic Care for Severe Acute Malnutrition can come from a variety of places: Referral from community Referral from home-based care teams Referral from another health center (HC), referral hospital (RH) or clinic Upon entrance to the pediatric ward, every child should be assessed by a clinician or nurse for Severe Acute Malnutrition. The assessment should include a history of the child s condition, taken from the caregiver. The healthcare worker should then give the child a full medical examination to rule out complications requiring Inpatient care, including oedemes, diarrhea, vomiting, temperature, appetite, respiration rate, anemia, superficial infections, alertness, and hydration status. If the child exhibits any of these complications, he/she should be referred to Inpatient care and treatment. 4

5 If the child exhibits Severe Acute Malnutrition (SAM) without complications, then that child should be enrolled in Outpatient Therapeutic Care for treatment using Plumpy nut. The following conditions represent SAM without complications, and thus eligibility for Plumpy nut: < -2 S.D. (<80%) Weight-for-Height Measurement (WHM) AND Middle-Upper Arm Circumference (MUAC) < 120mm OR Bilateral pitting oedemes + or ++ AND Eating Alert For HIV+ children, Plumpy nut eligibility is also < -2 S.D. WHM. Any form of malnutrition increases health risks in the already immuno-compromised body of an HIV+ child. For those children exhibiting < -3 S.D. WHM, special care must be taken to determine whether these children are eligible for OTC. The National Guidelines for Severe Malnutrition state that any child exhibiting < -3 S.D. WHM should be enrolled in Inpatient Care until stabilized. However, in very few cases, a child may exhibit < -3 S.D. WHM without any other complications in this case, the clinician may decide to enroll the child in Outpatient Therapeutic Care. 3.5 Referral Mechanisms to HIV Testing Due to the high prevalence of HIV in SAM children, and following the national protocol for Provider-Initiated Testing and Counseling (PITC), the Plumpy nut demonstration will strengthen referral mechanisms between diagnosis of SAM and HIV testing. Children who are diagnosed with Severe Acute Malnutrition and whose HIV status is unknown will be referred to the nearest VCCT services for HIV testing and counseling. If the child is <18 months old, he/she will be referred to the nearest facility that can take a blood sample to be sent for HIV PCR testing. 3.6 Outpatient Therapeutic Care and the Initial Demonstration of Plumpy nut If a child exhibits SAM without complications, he/she is eligible to enter Outpatient Therapeutic Care and receive Plumpy nut as a food supplement for treating SAM. The healthcare worker should assess the child s appetite by giving a small amount of Plumpy nut to the child. The healthcare worker must observe the child eating and accepting Plumpy nut before the child can be accepted for Outpatient care. A child who refuses to eat Plumpy nut should be referred to Inpatient care until appetite is re-established. Appetite must be tested each time the child returns to the Referral Hospital (RH), Health Center (HC) or clinic. Lack of appetite may indicate deterioration of the child s nutritional status as well as poor liver or gastrointestinal function. 5

6 If the SAM child accepts the Plumpy nut sample, the healthcare worker must then determine the proper dosing of Plumpy nut. As with F100, dosing for Plumpy nut is measured as 200kcal per kilogram of body weight per day (200kcal/kg/day). Each 92g packet of Plumpy nut contains 500 kcal. The number of packets consumed by the child per day is simplified to make adherence easier for the caregiver. The following chart outlines the proper dosing of Plumpy nut: Dosing Chart for Plumpy nut Weight of Packets per Packets per 2- Child (kg) Day Week Supply >13.5 Based on 200kcal/kg/day Based on 200kcal/kg/day As shown in the table above, the caregiver should be given a 2-week supply of Plumpy nut. In addition to this 2-week supply, a small buffer-stock (5-10 packets) should be given to the caregiver in case Plumpy nut runs out before the child s next clinical visit. As long as the child remains classified as SAM without complications, the child and caregiver should return to the RH/HC/clinic every two weeks for monitoring of growth and overall health status. At each clinical visit, the caregiver should receive an additional 2-week supply of Plumpy nut for the child. 3.7 Counseling on Plumpy nut for Caregivers Ensuring that caregivers hold sufficient understanding of the dosing and administration of Plumpy nut for their children is of the utmost importance. In training nurses and counselors, special attention will be given to the following key issues: Describing how to open the Plumpy nut packet and feed Plumpy nut to the child Defining how much Plumpy nut should be given to the child every day and at each dose o Usually ½ packet per dose, eaten up to 8 times per day (depending on total number of packets consumed per day) Explaining that clean water must always be given to the child while eating Plumpy nut so that the child stays hydrated. 100 ml water per dose of Plumpy nut is suggested. 6

7 Instructing about the proper storage of Plumpy nut. Plumpy nut does not need to be refrigerated but it should be kept out of the sun Explaining that Plumpy nut is a food supplement for treating Severe Acute Malnutrition and therefore should not be shared with other members of the family or community who may be hungry Clarifying instructions about the interaction of Plumpy nut and regular food o If the child is breastfeeding, the caregiver may continue breastfeeding and give Plumpy nut immediately after breast milk o For all other children, Plumpy nut must be given before any other food o If the child is still hungry after eating the correct dose of Plumpy nut, the child may be given a small amount of a balanced, nutritious meal until the child is full Special feeding counseling should be presented to caregivers on general nutrition for children and on the preparation of balanced, nutritious meals. In order to prevent the re-occurrence of severe acute malnutrition, caregivers must understand proper nutrition for children and learn the best ways for preparing cheap, balanced and nutritious meals. The National Nutrition Program s (NNP) Guidelines on Nutrition Education should inform the content of the counseling on childhood nutrition and food preparation. Building and strengthening links between feeding counseling and the treatment of SAM using Plumpy nut is important for improving and sustaining good health and proper nutrition for the child. 3.8 Using Plumpy nut in Inpatient Care for the treatment of SAM Plumpy nut can also be used in Inpatient Care as a substitute for F100 in SAM children. In this case, the doctor or nurse must decide whether to administer Plumpy nut to the child. Since Plumpy nut is nutritionally similar to F100, the National Guidelines for Severe Malnutrition will determine the duration of treatment and the monitoring protocol for any Plumpy nut used in an Inpatient setting. As stated in the national guidelines, Plumpy nut should only be given in Inpatient Care after the patient has been stabilized with an initial regimen of F75. For monitoring Plumpy nut in Inpatient Care, the standard monitoring forms for severe malnutrition should be used, but a note should be written stating that Plumpy nut was used instead of F100. In addition, the dosing of Plumpy nut should be recorded. 3.9 Follow-Up and Monitoring in Outpatient Therapeutic Care When an eligible child is referred to Outpatient Therapeutic Care (OTC) to treat SAM with Plumpy nut, a healthcare worker should fill out an OTC card. The development of this OTC card has been supported by CHAI in collaboration with all partners involved in the initial demonstration of Plumpy nut. The OTC card documents the SAM child s health status, and includes indicators for Weight-for-Height Measurement (WHM), medical complications, HIV status, and the number of packets of Plumpy nut given out. All OTC cards should be kept in the patient s file, which should remain at the RH/HC/clinic. 7

8 The progress of the child should be monitored with visits to the OTC site at the RH/HC/clinic very two weeks. These clinical visits will track the child s weight gain as well as other indicators of improved health, which will be recorded on the child s OTC card. At any visit, if the child s condition has deteriorated, the child should be immediately referred to Inpatient care. In order to more closely monitor the health of the SAM child, Home-Based Care (HBC) teams should make weekly visits to the child s home. HBC teams check on the child s progress, overall health status, and adherence to the Plumpy nut regimen. HBC teams reinforce educational messages about proper dosing and administration of Plumpy nut. Finally, HBC teams refer the child to an Inpatient facility immediately if indicated by the child s health symptoms. With both clinical visits and HBC check-ups, the child s health and nutrition status will be frequently monitored. The following is a sample schedule for the SAM child enrolled in Outpatient Therapeutic Care: Week 0 (Initial Visit) Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 RH/HC/Clinic Visit, HBC Visit HBC Visit RH/HC/Clinic Visit, HBC Visit HBC Visit RH/HC/Clinic Visit, HBC Visit HBC Visit RH/HC/Clinic Visit, HBC Visit This pattern should continue until child is discharged At the initial visit, the caregiver should be given a Patient Booklet for the treatment of malnutrition. The healthcare worker should record in the Patient Booklet the daily dosing of Plumpy nut, the number of total packets given out at the clinical visit, and the date of the next clinical visit (two weeks later). This booklet remains with the caregiver as a record of the child s progress. HBC teams can reference the Patient Booklet during their home visits in order to check recent health issues as well as adherence to the Plumpy nut regimen. At the end of each week, the healthcare worker in charge of Plumpy nut at each site should fill out the Weekly Totals for OTC sheet, which provides a record of Plumpy nut dosing and treatment outcomes. The number of children registered in the program should be checked against the number of active cards in the file. All children given Plumpy nut in both Inpatient and Outpatient care should be included. The weekly totals will be used to monitor the overall effectiveness of the initial demonstration. 8

9 3.10 Criteria for Discharge from Outpatient Therapeutic Care A SAM child receiving Outpatient Therapeutic Care should stay on Plumpy nut for a minimum of four (4) weeks, thereby ensuring that the child is seen for three consecutive clinical visits (including the initial visit). The child can be defined as cured of Severe Acute Malnutrition if he/she exhibits the following: > -1 S.D. (>90%) WHM for two consecutive health facility visits MUAC > 130 mm No oedemes for two consecutive health facility visits Sustained weight gain for two consecutive health facility visits Clinically well no complications The child may also be discharged if this child has defaulted, died, been transferred to Inpatient care, or been defined as non-cured. The discharge criteria are summarized in the following table: OTC Discharge Criteria Discharge Cured Minimum of 4 weeks in the program > -1 S.D WHM for two consecutive visits MUAC > 130 mm No oedemes for two consecutive visits Sustained weight gain for two consecutive visits Clinically well Transfer to Complementary Feeding Defaulted Absent for two consecutive OTC visits child may reenter OTC program if meets entrance criteria, but should fill out new OTC card Died Died during time registered in OTC Transferred to Inpatient Care Non-cured Condition has deteriorated and requires Inpatient therapeutic or hospital care Has not reached discharge cured criteria after three months refer to Inpatient care All discharge cured children should be transferred to standard Complementary Feeding care for a minimum of two months after discharge. Discharged non-cured children should also be administered Complimentary Feeding care. The Complementary Feeding care should include feeding counseling and demonstrations for the caregiver on how to prepare cheap, balanced and nutritious meals. Such education is essential to sustaining the child s nutritional status and overall health after the Plumpy nut regimen has been completed. 9

10 3.11 Safety Protocol Safety protocol for the use of Plumpy nut must be properly understood by all healthcare workers involved in the initial demonstration of Plumpy nut and by all caregivers of SAM children placed on a Plumpy nut regimen. Health complications noticed by the healthcare worker o The child should be referred to Inpatient care at the nearest RH/HC/clinic for any health complications and/or deterioration in the child s health status, whether determined during a clinical visit or an HBC visit. Health complications noticed by the caregiver o The child should not stop taking Plumpy nut when the child has mild diarrhea. o If the child has serious diarrhea, vomiting, fevers, or swelling, the caregiver must bring the child back to the RH/HC/clinic as soon as possible. With these symptoms, the caregiver must also temporarily stop dosing Plumpy nut to the child. The Plumpy nut regimen should only be restarted upon the doctor s or nurse s instructions, and only after the child is stabilized. Allergies o Though unlikely, there is a small chance that a child may have an allergic reaction to the peanut butter in Plumpy nut. The allergy may cause reactions in the form of rashes, hives, skin infections, swelling, shortness of breath, or anaphylactic shock. For any of these symptoms, the caregiver must discontinue dosing of Plumpy nut and bring the child to the nearest health facility immediately. o If the child presents with symptoms of an allergic reaction, healthcare workers should follow national protocol for the treatment of allergic reactions. Choking o The caregiver should be assured that the child will not choke when eating Plumpy nut. However, they should also be instructed that if the child starts to choke on Plumpy nut, the child should be brought into the nearest health facility immediately. 10

11 3.12 Partners in the Initial demonstration of Plumpy nut NCHADS Procurement, logistics management and distribution of Plumpy nut Storage of Plumpy nut through Central Medical Stores (CMS) of the MoH Technical assistance National Nutrition Programme (NNP) and NMCHC Support and technical assistance for design of initial demonstration Partner in overall management of initial demonstration Collaboration with all partners UNICEF Technical assistance with design, monitoring tools, and IEC materials Key management and implementation partner Clinton Foundation HIV/AIDS Initiative (CHAI) Support procurement of Plumpy nut (through UNITAID donation) Technical assistance in overall design, monitoring tools and IEC materials Technical assistance for training design and implementation of trainings Assistance with initial monitoring and evaluation Liaison with all partners National Pediatric Hospital Technical assistance with design, monitoring tools, and IEC materials Assistance in design and implementation of trainings Key implementing partner Chea Chumneas RH / MAGNA Technical assistance with design, monitoring tools, and IEC materials Assistance with design and implementation of trainings Key implementing partner TASK Technical assistance with design, monitoring tools, and IEC materials Key implementing partner French Red Cross Technical assistance with design and implementation Key implementing partner New Hope for Cambodian Children (NHCC) Technical assistance with design, monitoring tools and IEC materials Possible key implementing partner in the future 11

12 4. Intended Outcomes High recovery rates (>60-80%) for SAM children who receive Plumpy nut. Recovery is related to the discharge cured criteria, and is defined as a child who reaches his/her target WHM and sustains that weight gain. Such outcomes will indicate that Plumpy nut is a food supplement that can be used as an effective treatment for children with SAM in Cambodia. Acceptability of the Plumpy nut product by Cambodians. Cambodians are willing to take Plumpy nut as a food supplement for treating SAM and are able to adhere to the proper dosing of Plumpy nut. Demonstration that recovery rates for SAM in Outpatient Therapeutic Care are as high (or higher) than in Inpatient care. This will promote OTC as an acceptable method for treating children exhibiting SAM without complications. Improved referral mechanisms between malnutrition wards/clinics and HIV testing. Such strengthening will result in increased numbers of children exhibiting SAM who are tested for HIV. Demonstration that, in SAM HIV+ children, using Plumpy nut and improving nutrition can delay the onset/need for ARV treatment and improve ARV treatment outcomes. (This is an intended outcome for the medium- and long-term) Documentation of challenges and opportunities with the implementation of Plumpy nut, in order to improve implementation and facilitate scale-up of RUTF as a food supplement for treating SAM 5. The Future of RUTF in Cambodia Should the intended outcomes listed above be realized, RUTF in general (and Plumpy nut in particular) could be viewed as a viable, efficacious, and cost-effective alternative food supplement for treating children with Severe Acute Malnutrition. One goal is to inform policy on appropriate and effective practices to treat SAM, thereby integrating RUTF into national guidelines and protocols. Acceptability and consensus about the benefits of RUTF would promote the broad scale-up of RUTF as a preferred treatment for SAM across the country, thereby strengthening the service delivery of national health systems in the process. If positive treatment outcomes and high acceptability among Cambodians are demonstrated by the initial demonstration of Plumpy nut, these results will be used to rally support for the local Cambodian production of a Plumpy nut-like RUTF product. Local production would increase the cost-effectiveness of RUTF as a food supplement used to treat SAM and ensure the sustainability of RUTF in Cambodia. 12

13 References: Briend A. Possible use of spreads as a FOODlet for improving the diets of infants and young children. Food Nutrition Bulletin. Vol 3 (2002): pp Ciliberto, Michael A et al. Comparison of home-based therapy with Ready-to-use therapeutic food with standard therapy in the treatment of malnourished Malawian children: a controlled, clinical effectiveness trial. American Journal of Clinical Nutrition. Vol 81 (2005): pp Concern Worldwide. CTC Learning Forum Report: Integrating HIV Services with CTC. Vol 1, Issue 2 (1 April 2007): pp Diop, El Hadji Issakha et al. Comparison of the efficacy of a solid ready-to-use food and a liquid, milk-based diet for the rehabilitation of severely malnourished children: a randomized trial. American Journal of Clinical Nutrition. Vol 78 (2003): pp Emergency Nutrition Network. Operational Challenges of Implementing Community Therapeutic Care: ENN Report on an Inter-Agency Workshop. Washington, D.C.: ENN, Sandige, Heidi et al. Home-Based Treatment of Malnourished Malawian Children with Locally Produced or Imported Ready-to-Use Food. Journal of Pediatric Gastroenterol Nuntrition. Vol. 39 No 2 (August 2004): pp Valid International. Community-based Therapeutic Care (CTC): A Field Manual. 1 st ed. Valid International: Oxford, UK,