The Formula 75 diet plan, along with Formula 100, involves therapeutic milk products specifically designed to combat severe malnutrition, particularly in hospitalized children. These formulas are integral to therapeutic feeding centers, providing a structured approach to refeeding and nutritional rehabilitation.
Understanding F-75 and F-100
F-75 serves as the "starter" formula, while F-100 is the "catch-up" formula in the treatment of severe malnutrition. The numerical designations signify the caloric content per 100 ml of the product. F-75 provides 75 kcal and 0.9 g of protein per 100 mL, whereas F-100 delivers 100 kcal and 2.9 g of protein per 100 mL. Both formulations are energy-dense, rich in fat and protein, and supply a substantial amount of essential nutrients. They typically contain concentrated milk powder, food oil (sometimes grease), dextrin, and vitamin complexes, designed to be mixed with the local water supply. Variants such as Low Lactose F-75 and Lactose-Free F-75 exist to accommodate children with persistent diarrhea related to severe acute malnutrition.
Historical Context
In 1994, Action Against Hunger/Action Contre la Faim (ACF) spearheaded the use of milk formula F-100 in treating severe acute malnutrition. This practice has since been adopted by major humanitarian aid organizations globally.
Diagnosing Severe Acute Malnutrition
Severe acute malnutrition is identified by the presence of oedema in both feet or severe wasting, indicated by a weight-for-height/length score of <-3SD or a mid-upper arm circumference (MUAC) of less than 115 mm. The clinical conditions of kwashiorkor and severe wasting are treated similarly. Children with a weight-for-age score of <-3SD may exhibit stunting but not necessarily severe wasting, and these children do not require hospitalization unless they present with a serious illness.
Initial Assessment
The primary diagnostic features include:
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- Weight-for-length/height < -3SD (wasted)
- Mid-upper arm circumference < 115 mm
- Oedema of both feet (kwashiorkor with or without severe wasting)
Children with severe acute malnutrition undergo a comprehensive clinical examination to identify any general danger signs, medical complications, and to assess their appetite. Those with loss of appetite or medical complications require inpatient care, while those with a good appetite and no medical complications can be managed as outpatients.
Initial Assessment and History
Assess for general danger signs or emergency signs and take a history concerning:
- Recent intake of food and fluids
- Usual diet before the current illness
- Breastfeeding practices
- Duration and frequency of diarrhoea and vomiting
- Type of diarrhoea (watery/bloody)
- Loss of appetite
- Family circumstances
- Cough lasting more than 2 weeks
- Contact with tuberculosis
- Recent contact with measles
- Known or suspected HIV infection/exposure
Physical Examination
On examination, look for:
- Signs of shock: lethargy or unconsciousness; cold hands, slow capillary refill (> 3 s), or weak (low volume), rapid pulse and low blood pressure
- Signs of dehydration
- Severe palmar pallor
- Bilateral pitting oedema
- Eye signs of vitamin A deficiency: dry conjunctiva or cornea, Bitot spots, corneal ulceration, keratomalacia
- Localizing signs of infection, including ear and throat infections, skin infection, or pneumonia
- Signs of HIV infection
- Fever (temperature ≥ 37.5 °C or ≥ 99.5 °F) or hypothermia (rectal temperature < 35.5 °C or < 95.9 °F)
- Mouth ulcers
- Skin changes of kwashiorkor: hypo- or hyperpigmentation, desquamation, ulceration (spreading over limbs, thighs, genitalia, groin, and behind the ears), exudative lesions (resembling severe burns) often with secondary infection (including Candida)
Appetite Test
Conduct an appetite test by providing ready-to-use therapeutic food. Laboratory investigations should be conducted for Hb or EVF, especially if there is severe palmar pallor.
Organization of Care
Children with a good appetite (passing the appetite test) who are clinically well and alert should be treated as outpatients for uncomplicated severe acute malnutrition. Children with severe oedema +++ or a poor appetite (failing the appetite test) or who present with one or more general danger signs or medical conditions requiring admission should be treated as inpatients. On admission, a child with complicated severe acute malnutrition should be separated from infectious children and kept in a warm area (25-30 °C, with no draughts) or in a special nutrition unit if available, and constantly monitored. Facilities and sufficient staff should be available to ensure correct preparation of appropriate therapeutic foods and to feed the child regularly, day and night. Accurate weighing machines or MUAC tapes are needed, and records of the feeds given and the child's weight or anthropometric measurements should be kept so that progress can be monitored.
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General Inpatient Management
For triage assessment of children with severe acute malnutrition and management of shock, refer to relevant guidelines. When there is corneal ulceration, administer vitamin A, instill chloramphenicol or tetracycline and atropine drops into the eye, cover with a saline-soaked eye pad, and bandage.
Days 1-2
Address immediate life-threatening conditions such as hypoglycemia, hypothermia, and dehydration.
Days 3-7
Continue nutritional rehabilitation and monitor for potential complications.
Weeks 2-6
Focus on catch-up growth and prepare for discharge, ensuring the caregiver is educated on continued care at home.
Specific Management Protocols
Hypoglycaemia
All severely malnourished children are at risk of hypoglycaemia and, immediately on admission, should be given a feed or 10% glucose or sucrose. Frequent 2-hour feeding is important.
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Diagnosis: Hypoglycaemia is present when the blood glucose is < 3 mmol/litre (< 54 mg/dl). If blood glucose cannot be measured, it should be assumed that all children with severe acute malnutrition are hypoglycaemic and given treatment.
Treatment:
- Give 50 ml of 10% glucose or sucrose solution orally or by nasogastric tube, followed by the first feed as soon as possible.
- Give the first feed of F-75 therapeutic milk, if it is quickly available, and then continue with feeds every 2 h for 24 h; then continue feeds every 2 or 3 h, day and night.
- If the child is unconscious, treat with IV 10% glucose at 5 ml/kg or, if IV access cannot be quickly established, then give 10% glucose or sucrose solution by nasogastric tube. If IV glucose is not available, give one teaspoon of sugar moistened with one or two drops of water sublingually, and repeat every 20 min to prevent relapse.
- Start on appropriate IV or IM antibiotics.
Monitoring: Repeat blood glucose measurement after 30 minutes if the initial level was low. Monitor rectal temperature and level of consciousness, treating accordingly if they deteriorate.
Prevention: Feed every 2 h, starting immediately, or rehydrate first when dehydrated. Encourage mothers to help feed and keep the child warm.
Hypothermia
Hypothermia is very common in malnourished children and often indicates coexisting hypoglycaemia or serious infection.
Diagnosis: Assume hypothermia if the axillary temperature is < 35 °C (< 95°F) or does not register on a normal thermometer. Confirm with rectal temperature (< 35.5 °C or < 95.9 °F) when a low-reading thermometer is available.
Treatment:
- Treat routinely for hypoglycaemia and infection.
- Feed the child immediately and then every 2 h unless they have abdominal distension; if dehydrated, rehydrate first.
- Re-warm the child: Ensure the child is clothed, cover with a warmed blanket, and place a heater or lamp nearby, or use skin-to-skin contact with the mother.
- Give appropriate IV or IM antibiotics.
Monitoring: Take rectal temperature every 2 h until it rises to > 36.5 °C. Ensure the child is covered at all times, especially at night.
Prevention: Feed immediately and then every 2-3 h, day and night. Use the Kangaroo technique for infants, and avoid exposing the child to cold.
Dehydration
Dehydration tends to be overdiagnosed and its severity overestimated in children with severe acute malnutrition because it is difficult to determine dehydration accurately from clinical signs alone.
Treatment:
- Rehydrate slowly, either orally or by nasogastric tube, using oral rehydration solution for malnourished children (5-10ml/kg per h up to a maximum of 12 hours).
- Give ReSoMal rehydration fluid orally or by nasogastric tube:
- Give 5 ml/kg every 30 min for the first 2 h.
- Then give 5-10 ml/kg per h for the next 4-10 h on alternate hours, with F-75 formula.
- If not available then give half strength standard WHO oral rehydration solution with added potassium and glucose as per the ReSoMal recipe below, unless the child has cholera or profuse watery diarrhoea.
- If rehydration is still required at 10 h, give starter F-75 instead of ReSoMal, at the same times.
Monitoring: Monitor respiration and pulse rate, and urine output. Be alert for signs of overhydration.
Prevention: Continue breastfeeding if the child is breastfed. Initiate re-feeding with starter F-75, and give ReSoMal between feeds to replace stool losses.
Electrolyte Imbalance
All severely malnourished children have deficiencies of potassium and magnesium, which may take about 2 weeks to correct.
Treatment:
- Give extra potassium (3-4 mmol/kg per day).
- Give extra magnesium (0.4-0.6 mmol/kg per day).
- When rehydrating, give low sodium rehydration fluid (ReSoMal).
- Prepare food without added salt.
ReSoMal Recipe
ReSoMal (Rehydration Solution for Malnutrition) is a specialized oral rehydration solution designed for severely malnourished children. It has a lower sodium and higher potassium content compared to standard WHO ORS.
Ingredients:
- Water: 2 litres
- WHO ORS: One 1-litre packet
- Sucrose: 50 g
- Electrolyte/mineral solution: 40 ml
Electrolyte/mineral solution recipe:
- Potassium chloride (KCl): 224 g
- Tripotassium citrate: 8 g
- Magnesium chloride (MgCl2.6H2O): 7 g
- Zinc acetate (Zn acetate.2H2O): 8.2 g
- Copper sulfate (CuSO4.5H2O): 1.4 g
- Water to make up to 2500 ml
Additional Considerations
- Infection: Treat all infections promptly with appropriate antibiotics.
- Micronutrient Deficiencies: Provide daily supplements of vitamin A, folic acid, and zinc.
- Gentle Handling: Handle the child gently and provide emotional support.
- Stimulation: Provide a stimulating environment to encourage development.
- Preparation for Discharge: Involve the mother or caregiver in all aspects of care and provide education on feeding, hygiene, and follow-up care.
LRUTF (Locally-Prepared Ready-to-Use Therapeutic Food)
Some studies have explored the use of locally-prepared ready-to-use therapeutic food (LRUTF) as an alternative to F-100. LRUTF typically consists of a mixture of ground roasted peanuts, powdered milk, vegetable oil, powdered sugar, and a vitamin-mineral mix.
Preparation of LRUTF
The preparation of LRUTF involves grinding, mixing, and packaging. Peanuts are roasted at approximately 160º C for 40-60 minutes and then ground. Other ingredients, such as vegetable oil and powdered sugar, are blended in a mixer and packed.
Study on LRUTF vs. F100
One study compared the efficacy of LRUTF to a locally-prepared F100 diet in children with severe acute malnutrition. The study found that the rate of weight gain and duration of hospitalization were significantly less with the use of LRUTF.
Limitations
The study had some limitations, including the fact that it was not randomized or blinded, increasing the risk of selection bias.