I. INTRODUCTION AND BACKGROUND

People are considered to be malnourished (more specifically, undernourished) when they do not consume adequate calories, protein, and nutrients to satisfy their bodies’ growth and maintenance requirements (UNICEF, 2006).  Long dismissed as an indirect—even negligible—factor in child mortality, acute malnutrition is now indicted for its insidious and indeed major role in eight of the eleven million child deaths that occur worldwide on an annual basis (ScienceDaily, 2003).  Malnutrition is a major concern in Haiti, where 22% of children under the age of five are reported to be underweight (Population Reference Bureau, 2008).

Severe malnutrition is directly implicated in over a million child deaths each year (World Health Organization, 2006) and is defined as severe wasting (weight-for-height that is more than three standard deviations below the median World Health Organization (WHO) growth standards) and/or the presence of nutritional edema (swelling of the legs due to protein deficiency) (Prudhon, Prinzo, Briend, Daelmans, & Mason, 2006). There are about 20 million severely malnourished children worldwide, who make up an estimated 2% of the child population in underdeveloped countries (Briend, Prudhon, Prinzo, Daelmans, & Mason, 2006; World Health Organization, World Food Programme, United Nations System Standing Committee on Nutrition and United Nations Children’s Fund, 2007).  The prevalence of severe malnutrition in Haiti has most recently been reported as 2.2% (Childinfo, 2008).

Moderate malnutrition has a much higher prevalence than severe malnutrition and is responsible for a far greater number of child deaths annually; indeed, children with moderate malnutrition are up to 12 times more likely to succumb to preventable disease (e.g., measles, malaria, diarrhea, pneumonia) than well nourished children (ScienceDaily, 2003).  Defined by a weight-for-age score between two and three standard deviations below the median WHO child growth standards, moderate malnutrition can evolve into severe malnutrition if not treated effectively (Briend, Prudhon, Prinzo, Daelmans, & Mason, 2006).  The prevalence of moderate malnutrition in Haiti has most recently been reported as 6.9% (Childinfo, 2008).

The United Nation’s Millennium Development Goals were set out to galvanize nations and organizations across the globe to come together to meet the needs of the world’s poorest and most vulnerable inhabitants.  Addressing childhood malnutrition falls under two of these eight goals: eradicating extreme poverty and hunger (goal 1) and reducing child mortality (goal 4).

While international agencies have long engaged in preventive efforts to curb malnutrition in countries such as Haiti through the support of large-scale food provisioning programs (e.g., World Vision), therapeutic treatment programs for malnourished children are not nearly as widespread (Briend, Prudhon, Prinzo, Daelmans, & Mason, 2006).  While preventive programs are an essential part of combating malnutrition, they have not been proven effective in treating acute malnutrition (i.e., providing adequate energy for catch-up growth) (Briend, Prudhon, Prinzo, Daelmans, & Mason, 2006).  As a result, millions of children are continuing to die preventable deaths each year due to a lack of mobilization around this major public health issue.

II. DEFINITIONS

Anthropometry: The measurement of size, weight, and proportions of human body.

Bipedal “Pitting” Edema: Swelling of the feet and ankles caused by collection of fluid in the tissues (GEMSsite.com, 2008).  Bipedal edema is symptomatic of severe malnutrition (i.e., kwashiorkor) and results when fluid shifts out of the blood vessels in an attempt to maintain a balance of concentrations between the protein-deprived blood and the surrounding tissue.

Case-Finding: The process by which children with severe malnutrition are found and referred to a CTC program (Myatt, Khara, & Collins, 2006).

Community-based Rehabilitation:  “Treatment that is implemented at home with some external input, for example, from a health worker, or treatment that is given at a primary health clinic, a community day-care center, or a residential center in order to achieve catch-up growth” (Ashworth, 2006).

Community-based Therapeutic Care (CTC): A new model of delivering care that uses decentralized networks of outpatient treatment sites (e.g., an existing primary health-care center) small inpatient units, and large numbers of community-based volunteers to provide case detection and follow-up of patients in their home settings. (Myatt, Khara, & Collins, 2006)

Community-based Volunteer: An unpaid member of the community who volunteers his/her time to assist in case-finding or enrollment, for example, for a CTC program.

Day-Care Nutrition Center: First introduced 50 years ago, day-care nutrition centers consist of simple buildings where around 30 mildly to moderately malnourished children could attend for 6-8 hours a day, 6 days/week to receive three meals for 3-4 months.  Mothers would help with the cooking and cleaning and receive education on nutrition and child care.  Since their introduction day-care centers have waned in popularity, likely due to the time constraints placed on caregivers, who were obligated to attend for hours each day. (Ashworth, 2006)

Domiciliary Rehabilitation: Therapeutic care that is supplied to the caregiver to be provided in the patient’s home. Considered a “growth area” in therapeutic care since the advent of RUTF such as BP100 and Plumpy’nut (Ashworth, 2006).

Food Provisioning: The provisioning of food by international organizations (e.g., World Vision, the World Food Programme) to people living in food insecure areas of the developing world in an effort to prevent malnutrition.

Height-for-Age: An anthropometric measure used to calculate extent of stunting.

Kwashiorkor: A form of protein-energy malnutrition (PEM) that results from insufficient protein intake combined with fair to good consumption of total calories.  Often presenting with large, protuberant bellies, patients with kwashiorkor are characterized by bilateral pitting edema and a weight-for-height score greater than or equal to -2 SD. (Voorhees, 2006)

Marasmus: A form of protein-energy malnutrition (PEM) that results in a shrunken wasted appearance. Often observed in infants who are breastfeeding after a significant decrease in the amount of milk consumed or, more frequently, in those who are artificially fed.  Chronic diarrhea is often observed among marasmic patients. (Gehri, Stettler, & Di Paolo, 2006)

MedikaMamba: A locally produced RUTF manufactured in Cap Haitien, Haiti by Meds and Food for Kids, a St. Louis, USA-based nonprofit organization (http://www.medsandfoodforkids.org).

Middle Upper Arm Circumference (MUAC): An anthropometric measure used to assess extent of malnutrition, MUAC has been shown to perform better than other methods in detecting malnutrition and mortality risk and is the best method in terms of age independence, precision, accuracy, sensitivity, and specificity.  It is also simple, cheap, and acceptable in low-resource field settings where health workers may lack formal education or literacy. (Myatt, Khara, & Collins, 2006)

Moderate Malnutrition (MM):  Defined as a weight-for-age between -3 and -2 standard deviations below the median of the WHO child growth standards (World Health Organization, 2008).

Non-responder: A CTC patient who does not gain weight after being enrolled for at least 4 months and subjected to all available treatment options (Myatt, Khara, & Collins, 2006).

Outpatient Therapeutic Program (OTP): A program that treats children with severe malnutrition (without complications) on an outpatient basis through the provisioning of a ready-to-use therapeutic food (RUTF) and medicines to treat simple medical conditions.  Food and medicines are taken at home by the patient, who attends the OTP site on a weekly or bi-weekly (fortnightly) basis for monitoring and resupply. (Ashworth, 2006)

Outreach Worker: A salaried community health worker who is involved in case-finding, patient enrollment, and management for a CTC.

Percentage Weight Gain: A measurement used often in determining if a CTC patient is fit to be discharged from the program. Calculated as  ((Current weight-Weight at Admission)/(Weight at Admission x 100))

III. THERAPEUTIC FEEDING PROGRAMS AND THE CTC MODEL

V. GENERAL OBJECTIVES

·        To evaluate the potential of a St. Joseph Clinic-based OTP to treat acute child malnutrition in Thomassique under the CTC model.

·        To determine the efficacy of MedikaMamba as an RUTF based on improvements in MUAC, weight, and weight, along with hematocrit, blood glucose, and serum albumin levels.

·        To investigate the prevalence and scope of acute child malnutrition in Thomassique.

·        To establish an informed estimate for how costly it would be to run a CTC/OTP at St. Joseph’s on a permanent basis.

·        To raise awareness and education about the dangers of child malnutrition in Thomassique.

·        To identify and train a cadre of community volunteers to carry out an expanded program.

VI. STUDY PROTOCOLS

A. Case-Finding

Children with acute malnutrition will be recruited for the study through three primary mechanisms:

1.      Internal Referral: Clinic health professionals will be instructed to take the MUAC for any child patient who appears to be acutely malnourished.  If the child’s MUAC is ≤ 120 mm OR if he/she has bipedal pitting edema, they will refer the patient for enrollment into CTC.

2.      Community Outreach: Medical Missionaries fellows, the hired outreach worker, and community-based volunteers, will perform community outreach in Thomassique to identify children with acute malnutrition.  Children will be recruited for the study if they have an MUAC ≤ 120 mm OR if they appear to have bipedal pitting edema.

3.      Community Referrals: If neither internal referral nor community outreach results in adequate numbers of acutely malnourished children being referred to and enrolled in the OTP study, an effort will be made to identify key local leaders (e.g., priests, pastors, school principals) and inform them about the study so that they can make announcements at public gatherings.  Attendees will be instructed on the objectives of the study and told to inform parents of children who appear to be malnourished to take their children to St. Joseph Clinic, where they may qualify for enrollment in CTC.

B. CTC Enrollment and Screening for OTP Study

Adapted from a protocol published by the National Center for HIV/AIDS, Dermatology and STI (NCHADS) and Clinton Foundation HIV/AIDS Initiative – Cambodia, 2007.

1.      Children will initially have their MUAC, weight, height, and age (to be provided by the caregiver) taken and recorded by the OTP coordinator on an initial dossier (their “OTP Card”—see Appendix 1).  Children who have been referred by an outreach worker or community volunteer based on an MUAC measurement taken at their homes (or the presence of edema) will automatically qualify for enrollment based on the outreach person’s records in order to avoid the serious problem of rejected referrals.  However, a secondary MUAC reading will be taken by the coordinator and recorded as the formal reading for their OTP Card.  Discrepancies between MUAC readings will be noted and explored with the referring worker/volunteer.

2.      A child will qualify for enrollment in CTC if he/she meets ANY of the following criteria:

a.       MUAC ≤ 120 mm

b.      Weight-for-height is at least 2 standard deviations (SD) (≤ 80%) below the median WHO growth standards

c.       Presence of bipedal pitting edemes

3.      Children qualifying for enrollment will then be registered for entry into CTC after their caregivers give informed consent.  Once informed consent is provided, the child will be scheduled for a consultation with a clinic physician.

4.      The physician will provide the child with a general check-up, making sure to evaluate the following:

a.       Presence/grade of the child’s edemes

b.      Respiratory fitness

c.       Temperature

d.      Hydration

e.       Overall health

5.      The physician will draw blood from the child to send to the laboratory for serum albumin, hematocrit, and blood glucose testing. 

a.       If the child is anemic (as determined from the hematocrit reading), he/she will be prescribed the appropriate dosage of ferrous sulfate, to be filled at the pharmacy.

6.      If the child is severely malnourished (WHM  ≤ -3 S.D. or MUAC ≤ 110 mm) and the HIV status of his/her mother is unknown, the physician will also order an HIV antibody test to establish the child’s HIV status. 

a.       Any child who tests positive will be referred (and provided transportation) to Hinche to be enrolled in the Zanmi Lasante HIV/AIDS program there. 

7.      If the child presents symptoms of malaria, the physician will also order a malaria test.

a.       If the child has malaria, he/she will be given an initial dose of an anti-malarial (e.g., chloroquine) by the physician as well as a prescription, to be filled at the pharmacy.

8.      The physician will then decide if the child is to be admitted in the OTP study or kept as an in-patient according to the following criteria:

a.       The patient will be admitted for in-patient treatment if:

                                    i.      He/she has grade +++ bilateral pitting edemes OR

                                    ii.      Marasmic-kwashiorkor OR

                                   iii.      Bilateral pitting edemes AND one of the following:

1.      Anorexia

2.      Lower respiratory tract infection

3.      High fever

4.      Severe dehydration

5.      Severe Anemia

6.      Not alert

7.      Hypoglycemia

8.      Hypothermia

b.      In-patients will stay at the clinic for stabilization until they qualify for admission into the OTP.

c.       The patient will be enrolled in the Outpatient Therapeutic Program (OTP) if he/she satisfies the following criteria:

                                    i.      Weight-for-height percent of reference median (WHM) ≤-2 S.D. AND

                                   ii.      MUAC  ≤ 120 mm OR

                                  iii.      Presence of grade + or ++ bipedal pitting edemes.

                                  iv.      In addition to the above requirements, the consulting physician must certify the following:

1.      The child is clinically well

2.      The child has an appetite (the child must consume a small dose of the RUTF in front of the physician to qualify for enrollment in the OTP)

3.      The child is alert

9.      If the child is cleared for admission into the OTP, the physician will provide the OTP coordinator with the OTP Card and lab results from the child’s consultation.  A copy of these records will then be made by the OTP coordinator to be filed with the rest of the clinic’s patient files, while the original will be kept with the child’s OTP records. The child will then see the OTP coordinator for formal admission into the OTP.

C. OTP Admission

1.      The child and his/her caregiver will sit down with the OTP coordinator for formal admission into the OTP.  At this time, the child will be given Oral Rehydration Therapy (ORT) solution to aid in hydration, which he/she may consume during the following education session with the caregiver.

2.      The caregiver will be provided with a basic education session on the OTP program and MedikaMamba emphasizing the following messages (adapted from Collins, et al., 2006):

a.       Feeding the child MedikaMamba

                                 i.      MedikaMamba is a food and medicine for very thin children only.  It should not be shared.

                                ii.      Sick children often do not like to eat.  Give small regular meals of MedikaMamba and encourage the child to eat often (if possible eight meals a day).  Your child should have _____ doses a day.

                               iii.      MedikaMamba is the only food sick/thin children need to recover during their time in OTP.

                              iv.      Always give doses of MedikaMamba before any other food.  If child is still hungry after a full dose, he/she may be given a small amount of a nutritious meal until he/she becomes full.

                               v.      For young children, continue to put the child to the breast regularly.  Give dose of MedikaMamba immediately after breast milk.

                              vi.      Always offer plenty of clean water to drink while eating MedikaMamba (if possible, we will provide each caregiver with a Klorfasil system and educate them on how to use it at this point).

                               vii.      Use soap (to be provided) for the child’s hands and face before feeding if possible.

                              viii.      Keep food clean and covered.

                              ix.      Sick children get cold quickly.  Always keep the child covered and warm.

                              x.      With diarrhea, never stop feeding.  Give extra food and extra clean water.

                               xi.      Allergies

1.      Though unlikely, there is a small chance of allergic reacting to the peanut butter in MedikaMamba.

2.      In case of severe rashes, hives, skin infections, swelling, shortness of breath, or anaphylactic shock, the caregiver must discontinue provisioning of MedikaMamba and bring the child to the clinic immediately.

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

                            i.      If the child begins refusing food/not feeding well.

                           ii.      If the child develops a fever.

                           iii.      If the child becomes lethargic or stops responding to touch/voice.

                           iv.      If the child begins to breathe faster than normal.

                           v.      If the caregiver runs out of MedikaMamba for the child before the next scheduled visit.

c.       Importance of coming to follow-up visits

                           i.      Acute malnutrition is a potentially life-threatening condition that must be treated very seriously. 

                           ii.      MedikaMamba rations are provided on weekly basis and are crucial for the child to make a recovery. 

                           iii.      If the caregiver does not bring the child to the follow up appointments, his/her condition could deteriorate and become harder to treat in the future.

d.      Rate of improvement during therapy

                           i.      A simple explanation will be provided by the OTP coordinator regarding the child’s expected improvement throughout the course of the program/study.

3.      The caregiver will be asked throughout the education session to repeat the messages back to check that they have been fully understood.

4.      The caregiver will be provided with a OTP Patient Booklet, which will contain:

a.       Daily dosing of MedikaMamba

b.      Total amount of MedikaMamba provided at each visit.

c.       Date of the clinic visit a week later.

5.      After the education session has been completed and the OTP Patient Booklet has been filled out and reviewed with the caregiver, the child will be given folic acid and then brought to the government vaccine provider, who will provide him/her with injections of Vitamin A and the Measles Vaccination (if not already received).

6.      After the child’s injections are complete, the caregiver will be provided with a week’s worth of MedikaMamba for the child (plus a couple extra sachets as “buffer stock”).

D. OTP Follow-up Care

1.      At each visit to the clinic, the OTP coordinator will:

a.       Provide feeding counseling and instruction on how to prepare nutritious, balanced food to keep the child healthy after he/she is discharged from the OTP.

b.      Provide the child with any appropriate medications, according to Table 1 (below).

c.       Take updated anthropometric measurements for the child, including MUAC, weight, and height.

d.      Make updates to the child’s OTP Card and Patient Booklet.  The caregiver should bring the Patient Booklet to the clinic for each visit.

e.       Refer the child for additional consultation with a physician if deterioration is observed in the child’s condition.

*Vitamin A: Do not give if child has already received in last one month.  Do not give to children with edema until discharge from OTP.

**Folic Acid: Give on second visit if Fansidar is used as the antimalarial.

1.      When possible, the OTP coordinator, as well as community-based volunteers with the study, should make visits to the homes of the children in the program.   At these visits, the CTC staff member will:

a.       Check on the child’s progress and overall health status, along with his/her adherence to the prescribed MedikaMamba regimen.

                                                              i.      If any of the following symptoms is observed, the OTP staff member will refer the child back to the clinic immediately:

1.      Grade +++ bilateral pitting edemes

2.      Anorexia

3.      Lower respiratory tract infection

4.      High fever

5.      Severe dehydration

6.      Severe diarrhea

7.      Severe anemia

8.      Hypoglycemia

9.      Hypothermia

10.  Lack of alertness

b.      Follow up on any/all absences from weekly appointments with the OTP

2.      At the end of every week, the OTP coordinator will fill in the “weekly totals for OTP” sheet that records MedikaMamba dosing and outcomes:

a.       Number of children registered in the program will be checked against the number of “active” cards in the OTP file (not including discharges).

b.      Weekly totals will be used for monitoring and evaluation of the OTP for the study.

E. Discharge from the OTP Study

1.      A child may be discharged as “cured” of acute malnutrition if he/she meets the following criteria:

a.       Has been enrolled in the OTP for at least four weeks, with at least three recorded visits to the clinic (including the first).

b.      Has exhibited a WHM that is ≥ -1 S.D. (≥90%) for at least 2 consecutive visits.

c.       Has an MUAC ≥ 130 mm.

d.      Has not exhibited edemes for two consecutive visits to the clinic.

e.       Has had sustained weight gain for two consecutive visits to the clinic.

f.        Appears clinically well.

2.      Each child who appears to fulfill the above criteria will be taken to see a physician for a final consultation.  This consultation will involve a basic physical examination and blood draw, which will be used to run a final serum albumin, hematocrit, and blood glucose test s(along with any others that were done during the initial consultation) for the sake of comparison.

3.      If the child is cleared for discharge by the physician, he/she will return to the OTP coordinator, who will:

a.       Provide the caregiver with one week’s supply of MedikaMamba.

b.      Provide additional feeding counseling on good nutrition.

c.       Inform the caregiver of the food provisioning services available through WorldVision, if applicable.

4.      If a child is absent for three consecutive weeks, he/she will be discharged from the OTP study as “defaulted.”  The child may reenter the study but will have to receive a new OTP Card and go through the entry process once again.

5.      If a child has not achieved the criteria necessary to be discharged as “cured” after three months, he/she will be discharged as “non-cured” and referred to a physician for a consultation and possible admission as an in-patient.

6.      If a child dies during their time registered in the OTP study, he/she will be discharged as “died.”

VII. DATA AND ANALYSIS

Detailed records will be kept on each child’s progress throughout the study.  In addition to the complete set of health information (e.g., the physician’s qualitative notes, as well as the quantitative figures such as the child’s serum albumin, hematocrit, and blood glucose levels) that will be collected on admission (see VI. Study Protocols – CTC Enrollment and Screening for OTP Study – Sections 1-6) and discharge (see VI. Study Protocols – Discharge from the OTP Study – Section 2), the child’s MUAC, weight, and height will be taken by the OTP coordinator at each weekly visit (including admission and discharge).  These data will allow for paired comparisons to be made between the pre- and post-treatment data sets (on both individual and group levels), as well as average rates of improvement (e.g., g/kg/day).  Finally, discharge information (i.e., % cured, % defaulted, % non-cured, % died) will be kept to determine the efficacy of the OTP study intervention in comparison to other similar programs.

VIII. SUPPLIES & BUDGET

*This budget is extremely conservative.  The Hospital Albert Schweitzer was able to execute their emergency program for an average of $36 per child using MedikaMamba, and it is likely that the actual amount of MedikaMamba per child will come out to be substantially lower than the $68 quoted by Meds and Foods for Kids.

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