SUMMARY 

This document is a working plan for a pilot therapeutic feeding program to respond to a crisis of severe acute malnutrition in children that we are facing in our clinic in Achham. There are comprehensive and authoritative guidelines on the clinical and programmatic management of childhood malnutrition (see Refs); the intent of this document is not in any way to duplicate or replace those. Rather, this outlines the program and clinical procedures that we have adapted to our setting, as well as succinct details of clinical management.

 

Live sync files: \Clinic\Protocols\PrimaryCare\SAM 

References: MSF nutrition manual, WHO nutrition manual

Contact: sanjay (sanjay@nyayahealth.org), jason (jason@nyayahealth.org) and sachin (sachin.desai@yale.edu)

 

SUMMARY  PROTOCOL OVERVIEW SELECTION CRITERIA INTAKE COUNSELING CLINICAL MANAGEMENT Initial Clinical Evaluation Inpatient versus Outpatient Therapy Fluids Hypoglycemia Hypothermia Vitamin A Deficiency Antibiotics Micronutrients Therapeutic Feeding Assessing Progress Outpatient Follow-up Duration and Endpoints Managing Default Managing Treatment Failure After Completion of Therapeutic Feeding Program MONITORING AND EVALUATION  ACTION PLAN FORMS REFERENCES REMAINING QUESTIONS

 

PROTOCOL OVERVIEW

 

Note: Currently we are transitioning from this basic protocol to a full protocol in partnership with UNICEF:

-Implementation plan for community-based management of acute malnutrition: CMAM national level MOU document v6-10March-Final without budget.doc

-Treatment guidelines for outpatient therapy: Treatment Guidelines OTP - 30Mar2009_final.doc

-National medical protocol: Medical Protocol CMAM for Pilot_30Mar09_final.doc

-Nutrition assessment card: CMAM Nepal Formats English 30mar09.xls

 

 

Existing basic protocol: 

1. All children (age 6 months to 5 years) from the wards in which our CHWs are working will be screened for SAM. Those with MUAC < 110 mm or bilateral pitting pedal edema will be referred to the clinic for further anthropometric and medical evaluation

2. All children (age 6 months to 5 years) presenting to the Nyaya Health clinic should be weighed and have their height recorded (prior to being seen by the physician).

3. Children identified in the above manner who have bilateral pedal edema or Weight-for-Height Z Score < 3 or less than 70% of median will be considered for inclusion in the program. These children should be evaluated by the physician (as detailed below).

4. For first phase of the program, we will therapeutic feeding to 10 children with SAM, on a first-come, first-serve basis. In the second phase of the program, we will provide therapeutic feeding to 20 children residing in our target wards and 20 children not residing in our wards but residing within the 4 nearby VDCs (Siddeswor, Mastemandu, Riddhikot, )

5. For children receiving treatment in the clinic, they should return to the clinic weekly. At these visits, they should be: weighed, screened for evidence of infection, and given a one week supply of theraputic food.

6. For children receiving treatment in the community, they should be seen twice weekly by the CHW for the first 4 weeks, then once weekly. These children/mothers should follow up at the clinic once every two weeks

7. Children may be “discharged” from the program when the meet all of the following criteria: completed 2 months in the program, weight for height >=90%, no edema for a minimum of 2 weeks, evidence of sustained weight gain (for 3 consecutive weeks), patient judged by physician to be ‘clinically well’.

Per MSF Guidelines (Discharged Cured Criteria – all criteria must be met)

- W/H > 2 Z score on two consecutive weights ( 3 consecutive days in inpatients, 2 consecutive weeks in outpatients)

- MUAC> 110 mm

- absence of edema for 7 days minimum for kwashiorkor

- no significant associated pathology or ongoing antibiotic treatment (apart from TB patients)

- up to date measles vaccine

8. If at 8 weeks, the child has not met the following criteria, she should be evaluated by the physician to ensure that there is not an underlying illness.

9. After discharge, the mothers should be instructed to bring their child for return visits every 2 months for the first year. At these visits, the children should be weighed and measured, evaluated for relapse into SAM, and assessed for symptoms of illness.

10. Checklist for discharge

 

 

 

SELECTION CRITERIA

 

Eligibility:

1. Children are eligible for the program if they have bilateral pedal edema or weight-for-height Z score <70% of the median.1.

WHO Weight-for-length charts and tables

2. Live within 3 hours travel-time to the clinic

3. Parents agree to bring the child to the clinic weekly during treatment and then q2 months follow up visit for following year

4. For HIV-Infected patients:

- The recruitment criteria proposed for supplementary feeding were BMI less than 18.5 for adults, MUAC less than 22cm for pregnant and lactating mothers and weight for height less than 80% or MUAC less than 12cm for children.

- The suggested recruitment criteria for therapeutic feeding were BMI less than 16.0 for adults, pregnant and lactating mothers with Mid-Upper arm circumference (MUAC) less than 20 cm and children whose weight-for-height is less 70% and MUAC less than 11 cm.

See:

http://www.ghdonline.org/adherence/resource/integration-of-nutrition-in-the-antiretroviral-the/

and

http://model.pih.org/nutrition

MSF HIV guidelines state for adults  state BMI<17 and/or MUAC< 160mm and/or +3 edema (feet, legs, and other parts of the body)

- HIV ( 6mo – 18yrs) W/H< 80% and/or MUAC <110mm and/or bilateral edema

- these both are for therapeutic feeding

 

INTAKE

 

Upload intake forms here

 

COUNSELING

 

Counseling of patients should include the following domains (each of these domains are on the intake form and listed as dated items completed by the clinician, similar to prescriptions):

1. How to appropriately feed the child the TF.

The first dose is done at the clinic with the supervision of the treating midwife. Subsequent weekly follow-up visits will include a question by the midwife, "Please show me how you have been feeding your child." This will be done weekly for re-enforcement.

2. How to appropriately feed the child regular food.

Encourage breastfeeding to mothers of any children <1 years old.

If breastfeeding and older than 6 months, first encourage breastfeeding and try breastfeeding ~15min, then feed solid food at least 3 times per day

If not breastfeeding, feed solid food at least 5 times per day

3. When to return to the clinic outside of regular follow-up visits

If the child has any of the following, please bring him or her in immediately:

-not feeding well

-not responding to voice or touch/lethargic

-breathing faster than normal

-fever

4. Importance of coming to follow-up visits

The clinician must emphasize to the parent that the child's condition is severe and must be treated seriously. Where applicable, the clinician will also discuss the role of the CHW that is being used for outreach.

5. The rate of improvement during therapy.

The midwife will discuss in simple terms the expected improvement of the child.

We will pursue more detailed questions about dietary history, discrimination (particularly towards girl or disabled children, which is very common). The long-term goal is a full "development intervention", which would be aimed at addressing food security and the larger issues that lead to chronic and endemic malnutrition. On this wiki page, we are focussed on treating SAM clinically, then we will expand our services to include more comprehensive social interventions.

 

CLINICAL MANAGEMENT

 

This is a concise summary of the steps and clinical considerations. The clinicians should thoroughly familiarize themselves with: "WHO. Management of the child with a serious infection or severe malnutrition", pages 80-91.

 

Initial Clinical Evaluation

 

All malnourished children should be evaluated by a clinician. Check for edema, appetite, vomiting, temperature, respiration rate, anemia, superficial infections, alertness and hydration status. Treat illnesses/infections, fluids for hypovolemia, etc.

 

Inpatient versus Outpatient Therapy

 

In some settings, 70% of children with SAM have been treated successfully as outpatients.

Children can be managed as outpatients if they have no complications and have a good appetite, are alert, and appear clinically well. The first three feedings (spaced 1-2 hours apart) should be observed by the clinic staff to ensure that the child is able to eat the complete recommended amount and that the mother is feeding appropriately.

Children should be managed as inpatients if they have any of the following:

1. Poor Appetite – the child cannot eat the first three therapeutic feedings completely

2. Infections

3. Fever

4. Severe Palmar Pallor

5. Severe Dehydration

6. Lethargy / Not Alert

7. Hypothermia

 

 

Fluids

 

The WHO notes that dehydration tends to be overdiagnosed in malnourished children. They recommend giving IV fluids only when child is in shock or too lethargic to take PO, otherwise treating with oral rehydration.

 

If child presents with lethargy or shock, give RL at 15 ml/kg over 1 hr, repeat once if needed. Then:

• If child improves clinically with IV fluid bolus then proceed with oral rehydration;
• If child does not improve with IV fluid bolus then stop IV, commence rehydration via NGT, and treat with broad-spectrum antibiotics. 

 

When rehydrating, give a low sodium rehydration fluid, even if serum sodium is low, as the patient may be total body hypernatremic. It is very, very important to provide potassium and magnesium replacement. Clinical signs of dehydration are unreliable in the severely malnourished child. Inappropriate rehydration due to an incorrect diagnosis can be fatal due to volume excess.  ReSoMal (Rehydration Solution for Malnutrition) is a rehydration solution, is not appropriate for simple thirst (give plain water), and should not be given with RUTF (the products together will produce an excessive renal solute load).

 

The recommended oral rehydration protocol is as follows:

• give ReSoMal at 10 ml/kg/hr for the first two hours, then at 5 ml/kg/hr until dehydration corrected
• give F75 or F100 milk at meal hours with same volume used for ReSoMal
• reevaluate patient every two hours
• stop ReSoMal if increase in HR or RR, appearance of peripheral edema, or abdominal distention
• rehydration therapy can be discontinued when patient is no longer thirsty and adequate urine has passed

 

 

Hypoglycemia

 

for severe cases (vomiting, severe lethargy, obtundation, coma), use D50 IV 1 ml/kg, and relay with sugar water (PO or IV) and think septicemia.

+/- checking blood glucose

administer IV or PO if suspect, or just provide glucose regardless. If child can take PO, give:

1 teaspoon of sugar in 3.5 tablespoons of water (5 mg in 50 ml D50 by PO or NG)

Then:

1st feed (divide into 4 equal amounts and give at half-hourly intervals)

Then feed q 2 hours for first day.

 

Hypothermia

 

If temp < 35 degrees, cover child with a warm blanket or put the child on the mother’s bare abdomen or chest and cover both with blanket. Check for hypoglycemia when hypothermia is found.

 

Vitamin A Deficiency

 

Screen for corneal ulceration, sign of vitamin A deficiency. Treat with chloramphenicol or tetracycline eye drops and vitamin A tablets.

while vitamin A (retinol) is given as part of systematic treatment (200,000 capsules dosed by weight), it should not be given if the child has received a mega-dose in the last 4 months before admission, unless the child has xeropthalmia (then, repeat dose)

 

Antibiotics

 

The WHO recommends the following:

If no complications: give Cotrimoxazole x 5 days (or amoxicilllin per MSF). Give mebendazle or albendazole.

If complications (hypoglycemia, hypothermia, or lethargy): give Amp/Gent x 5 days. Can consider metronidazole as well.

If child fails to improve in 48 hours: add chloramphenicol.

 

Micronutrients

 

Be aware of risk of double-dosing of micronutrients given inclusion of micronutrients into therapeutic foods.

1. Multivitamin daily x 2 weeks
2. Folic acid (5mg on day 1, then 1mg daily) x 2 weeks
3. Zinc (2mg/kg/day) x 2 weeks
4. Copper (0.3mg/kg/day) x 2 weeks
5. Vitamin A (age < 6 mo: 50,000 IU, 6-12 mo 100,000 IU, >12 mo 200,00 IU) x 1 on day 1
6. Iron Sulfate: wait two weeks and until child gaining weight. Then 3mg/kg/day (consider w/ Vit C to improve absorption)

 

Keep in mind that F75 and F100 have most of these nutrients EXCEPT iron. RUTF contains the same nutrients as therapeutic milk but also has iron. This difference is important because iron-containing foods should be avoided during the first two weeks of treatment.

 

Therapeutic Feeding

**break it into the phase I (stabilization [F75]), phase II (subclassified into inpatient re-nutrition [F100 and supp feeding] and outpatient renutrition [supp nutrition])** (using MSF tables)

Our current choice of therapeutic feed is Nutrimix, which is 400 kCal / 100g.

 

Outpatient

If the patient has no warning signs and can be treated as an outpatient, start with 200 kCal/kg/day (50g/kg/day). Feedings should be in small quantities ~6-8 times/day. If the mother is breastfeeding, she should feed before giving therapeutic food. Observe the first 3 feedings.

Inpatient

If the patient has any warning signs, she should be hospitalized until she is showing signs of recovery. For these patients:

1. Feed 100 kCal/kg/day (25g/kg/day). Feed by OG or NG tube if necessary.

2. Liquid max: 130 ml/kg/day (100 ml/kg/day if edema present)

3. If breastfeeding, breastfeed attempt 15 min first, then RUTF

4. Use a spoon if possible, else a dropper.

5. For the first few days, feed every 2 hours, may gradually space to q4 hours

After recovering well, change to quantity and method as described in outpatient feeding.

NOTE: monitor for signs of heart failure, which are more likely with more rapid/aggressive feeding schedules. Reduce the fluid amount if signs of heart failure develop.

 

Assessing Progress

 

1. Weight child every morning before feeding. Plot weight.

2. Calculate weight gain q3 day (inpt) or at every outpatient visit.

3. If weight gain <5g/kg/day, this is poor. Reassess child from beginning.

4. If weight gain 5-10 kg/day, this is moderate. Ensure intake goals are met, screen for infections.

 

Outpatient Follow-up

 

For children receiving treatment in the clinic, they should return to the clinic weekly. At these visits, they should be: weighed, screened for evidence of infection, and given a one week supply of therapeutic food. If a child is not brought for a follow up visit, an outreach worker should be sent after 3 days to visit the home of the child and bring the child and parent to the clinic.

For children receiving treatment in the community, they should be seen twice weekly by the CHW for the first 4 weeks, then once weekly. These children/mothers should follow up at the clinic once every two weeks.

 

Duration and Endpoints

 

A typical duration of treatment is 8 to 10 weeks.

Recovery is defined as 90% weight for length. Child may still have low weight for age due to stunting. Upon reaching this milestone, the child may be discharged from the program.

Additional discharge criteria:

1. completed 2 months in the program

2. no edema for a minimum of 2 weeks

3. evidence of sustained weight gain (for 3 consecutive weeks)

4. patient judged by physician to be ‘clinically well’.

other documented discharge criteria: 1) W/H > 2 Z scores (80%) on 2 consecutive weights 3) consecutive days in inpts, 2 consecutive wks in outpts)  2) MUAC > 110cm  3)absence of edema for 7 days min for kwashiorkor  4) min total length of stay in the program of 14 days  5) no sig associated pathology or ongoing abx tx (apart from TB pts)  5) up to date measles vaccination

 

Managing Default

 

Patients who fail to show up to a two consecutive weekly follow-up appointments are considered lost to follow-up. A CHW or other outreach worker should be sent to their homes to see the patient, assess the situation, and encourage them to return to the clinic as soon as possible.

 

Managing Treatment Failure

 

to be completed

 

After Completion of Therapeutic Feeding Program

 

Ensure that child is up to date with vaccinations. After discharge from the program, the child should be brought back to the clinic at 1, 2, 4 weeks, then monthly for 6 months. Weight and height should be recorded as screening for relapse.

 

MONITORING AND EVALUATION 

The main outcomes of this program include:

Accessibility

• number of children screened and enrolled by village development committee, sex, and caste

Effectiveness

• percentage of total visits attended per child
• achievement of clinical goals at four weeks and eight weeks

 

ACTION PLAN

 

Logistics and Scope

• Identify reliable supplier of RUTF
• Decide upon the target population and initial number of children covered
• Inpatient will be performed at the Sanfe Bagar clinic, since that is the only physician-run health services in Achham.  All outpatient services will be managed through this clinic. 
• Ideally, the program would be initiated at the Bayalpata hospital once the facility is ready and the plans with the Ministry are approved.

 

Staffing and Training

• Recruit a program manager to oversee the program
• Aditya should also conduct a training session for Jhapat, as therapeutic feeding and management of severe acute malnutrition is not part of a medical school curriculum. One hour should be sufficient, just going over some of the most important principles of medical management of SAM and how our program will be functioning. Jason and Aditya can develop the ‘curriculum’ for this brief training (i.e. a powerpoint for them to flip through together).

 

Clinical Management

• Put a height measure in the clinic and ensure that staff use it correctly
• Include height and weight measurements on OPD forms for ALL children aged 6 months-5 years who present to the clinic. Ensure that all children coming through the OPD are checked Height-for-Weight Z score < 3 and bilateral pedal edema.
• Find examples of forms used for therapeutic feeding programs and adapt them for our use.
• Review of operations and of data, along with interviews of the parents of children receiving treatment, should be undertaken upon completion of therapy.

 

Outreach

• Identify health posts that can participate in the program.  The main role of the health post would be to serve a CHW function.  Given their poor state, the health posts will not be providing clinical care.  The number of participating health posts would depend upon the capacity of the health posts' staff and on the target number of children covered.
• Conduct a brief training about the malnutrition program with the CHWs to explain the scope of the program and their roles in it (they have already been given training generally on malnutrition and on measuring MUAC, so this will be a practical briefing on how our program will work, how many patients are eligible, what their role will be, etc).

 

Financial

• compile fundraising materials to expand program to cover more children. 
• determine tentative project budget

 

FORMS

 

Clinical record

Home-based CHW record

 

REFERENCES

 

Clinical:

 

Defourny, I., et al. A Large-Scale Distribution of Milk-Based Fortified Spreads: Evidence for a New Approach in Regions with High Burden of Acute Malnutrition. PLoS Medicine, PLoS ONE 4(5): e5455. 

 

WHO. Management of the child with a serious infection or severe malnutrition. 2000.

(particularly pages 80-91)

 

Collins S, Dent N, Binns P, Bahwere P, Sadler K, Hallam A.  Management of severe acute malnutrition in children. Lancet 2006. 368(9551):1992-2000. Available on Foldershare in Clinic/Protocols/Malnutrition

 

Programmatic:

 

Collins S, Sadler K, Dent N, Khara T, Guerrero S, Myatt M, Saboya Mo, Walsh A. Key issues in the success of community-based management of severe malnutrition. 2005. Technical Background Paper. available at:

http://www.who.int/nutrition/topics/backgroundpapers_Key_issues.pdf

 

2007 PIH Symposium on Integrating Health, Nutrition and Food Security. Powerpoint presentations from conference available on:

http://pih.org/inforesources/IHSJ_Food_Conference_2007_presentations.html

 

REMAINING QUESTIONS

 

1. Decide on plumpynut vs. plumpydoze. The latter is available as a food supplement and mix, and may be shared with other family members, but requires water.

2. Do we have the micronutrients recommended in protocol above (copper, iron, zinc)

3. specific documentation of admitted, readmitted, discharged, defaulted, death, and transfer statistics

4. first come, first serve vs worst first

5. should be a definitive feeding schedule (see MSF manual), as well as specific recs for F75, F100, resomal, water, and ng feeding

6. have systematic treatment with albendazole or mebendazole (not given systematically to kids< 1yr, unless signs or evidence of parasitic infection.  > 1yr given systematically).

7. if there is some malaria, include in the protocol

8. issues that are commonly seen in TFC/SFP that should be considered in the protocol: diarrhea, resp tract infections (URI, LRTI, wheezing, TB), septicemia, shock, anemia, dehydration (use of resomal vs IV), oral/digestive/systemic fungal infections, cutaneous infections, and sedation/analgesia (esp with skin lesions found with some of the kwash kids).

 

 

Ready-to-use Therapeutic Food (RUTF) versus Porridge

Read-to-use Therapeutic Foods (RUTF) have revolutionized the treatment of severe acute malnutrition in resource limited settings. These have signficant advantages over the other alternatives, such as porride-based TF (e.g., Nutrimix) or liquid milk (e.g., F-100; not readily available in Nepal). Advantages include:

#they are more dense in nutrients and contain the important nutrients needed by young children

#they can be stored for long periods of time (2 year shelf life) without significant risk of contamination (unlike other therapeutic foods such as F100 which are ideal bacterial growth media)

#they require no preparation, making them easier to use AND reducing the risk of contamination by dirty water

#they are not as easily shared (diverted) by other members of a family

 

Their superiority in treatment of severe acute malnutrition is evident. Randomized trials have shown this:

 

El Hadji Issakha Diop, Nicole Idohou Dossou, Marie Madeleine Ndour, André Briend and Salimata Wade. 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, No. 2, 302-307, August 2003

 

Manary MJ, Ndkeha MJ, Ashorn P, Maleta K, Briend A. Home based therapy for severe malnutrition with ready-to-use food. Arch Dis Child 2004; 89: 557–61.

Notably: in this study, there were 3 arms: One received RUTF meeting 100% of predicted energy requirements (175kCal/kg/day). The second received a supplement of ~500 kCal (~33%) of energy requirements. Third received enough maize/soy flour for entire family, and separate MVI/mineral supplement. Group 1 was notably superior to groups 2 and 3, and the RUTF supplement performed comparably to maize/soy flour.

 

Description of nutrimix is available at: SharedNyaya/Clinic/Protocols/Malnutrition/Nutrimix.pdf

In brief, per 100g it has: 400 kCal. 16 gm protein, 6 gm fat

Composition: 30% Wheat, 30% Maize, 25% soybean, 14% sugar.

Fortified with vitamins A, B1,2,3,12, C. Folate, Calcium, Zinc, and Iron.

It is recommended to prepare as mixed with boiled water.

It was tested for contents and met WFP standards.

The cost is Rs 42-45 / Kg ($0.56-0.60/kg), depending on bulk purchased.

 

In contrast, Cipla's Nutrinut (generic version of plumpy'nut) was offered to us at Nepali Rupees 52 (~75 US cents) for a 500 Kcal bar

(92 grams net weight; 12.5 grams protein; 32.86 grams lipid). It has the same nutritional content of F-100 milk formula and plumpy'nut. Its micronutrient composition can be found here:

http://en.wikipedia.org/wiki/Plumpy%27nut

For a typical 2-3 times daily, four week course, the cost is about $50 per child.

 

On a kcal basis, RUTF are more expensive than therapeutic foods. Cipla's Nutrinut (generic version of Plumpy'nut) is about 10 times more per Kcal than the Nutrimix porridge we are looking at. It's a crude way to compare products but gives a rough sense. For an organization with severe financial constraints, where the demand for our services is far outpacing our ability to supply them, we need to look at the relatively efficacy of the products in the context of their relative costs to determine how we can best serve the local population.

Cost comparison:

http://spreadsheets.google.com/a/nyayahealth.org/ccc?key=p-TJjzE7A-O75X7BGZZgnPA&hl=en

 

MSF has a new campaign advocating for more investment in research and delivery of RUTF and is critical of porridges (the "Food is Not Enough" campaign). They make the important point that fighting hunger is often conflated with treating malnutrition. While we have tools to do the latter (and RUTF has transformed our ability to do so), medical science isn't equipped to address the former. They argue for investment in what we know works for malnutrition, which is RUTF, and that this has been demonstrated to save lives, rather than generic "food aid" which is better for adults and for "fighting hunger".

5-minute video about this: http://www.podcast.msf.org/webload/2007/MSF_Launch_Food_Is_Not_Enough.mov

Campaign Website:

http://www.msf.org/msfinternational/invoke.cfm?objectid=88903F07-15C5-F00A-2573B0F07D1AF97E&component=toolkit.report&method=full_html&mode=view

 

RUTF For Prevention of Severe Acute Malnutrition/Wasting

 

A recent article in the Journal of the American Medical Association (JAMA) described a program utilizing RUTF in Niger in patients without moderate to severe wasting to prevent the development of wasting.  The study was done in a region of high levels of food insecurity and resultant wasting among children, and food supplementation was given during the time period preceding harvest in which there was traditionally a spike in the prevalence of wasting.  Twelve villages were cluster randomized into two groups: in 6 villages, all children with weight-for-height Z scores >80% received a sachet of RUTF (92g, 500 kCal) every day for 3 months; in the other 6 villages, children did not receive sachets.  All children with weight-for-height < 80% (at baseline or any time during the survey) were referred for therapeutic treatment of wasting (2 sachets/day of RUTF with weekly follow up).  The end result was a significant reduction in wasting (36% reduction) and severe wasting (58% reduction) in the intervention groups.  Mortality trended towards being lower, but the difference was not statistically significant. 

Ref:

Isanaka et al. Effect of Preventive Supplementation with Ready-to-Use Therapeutic Food on the Nutritional Status, Mortality, and Morbidity of Children Aged 6 to 60 Months in Niger. JAMA 2009; 301(3):277-285.