Home-based therapy with ready-to-use therapeutic food is of benefit to malnourished, HIV-infected Malawian children. 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. Effectiveness of ready-to-use therapeutic food compared to a corn/soy-blend-based pre-mix for the treatment of childhood moderate acute malnutrition in Niger. A ready-to-use therapeutic food containing 10% milk is less effective than one with 25% milk in the treatment of severely malnourished children.
To determine if home-based nutritional therapy will benefit a significant fraction of malnourished, HIV-infected Malawian children, and to determine if ready-to-use therapeutic food (RUTF) is more effective in home-based nutritional therapy than traditional foods.
                93 HIV-positive children >1 y old discharged from the nutrition unit in Blantyre, Malawi were systematically allocated to one of three dietary regimens: RUTF, RUTF supplement or blended maize/soy flour. RUTF and maize/soy flour provided 730 kJ x kg(-1) x d(-1), while the RUTF supplement provided a fixed amount of energy, 2100 kJ/d. These children did not receive antiretroviral chemotherapy. Children were followed fortnightly. Children completed the study when they reached 100% weight-for-height, relapsed or died. Outcomes were compared using regression modeling to account for differences in the severity of malnutrition between the dietary groups.
                52/93 (56%) of all children reached 100% weight-for-height. Regression modeling found that the children receiving RUTF gained weight more rapidly and were more likely to reach 100% weight-for-height than the other two dietary groups (p < 0.05).
                More than half of malnourished, HIV-infected children not receiving antiretroviral chemotherapy benefit from home-based nutritional rehabilitation. Home-based therapy RUTF is associated with more rapid weight gain and a higher likelihood of reaching 100% weight-for-height. Childhood malnutrition is common in Malawi, and the standard treatment, which follows international guidelines, results in poor recovery rates. Higher recovery rates have been seen in pilot studies of home-based therapy with ready-to-use therapeutic food (RUTF).
                The objective was to compare the recovery rates among children with moderate and severe wasting, kwashiorkor, or both receiving either home-based therapy with RUTF or standard inpatient therapy.
                A controlled, comparative, clinical effectiveness trial was conducted in southern Malawi with 1178 malnourished children. Children were systematically allocated to either standard therapy (186 children) or home-based therapy with RUTF (992 children) according to a stepped wedge design to control for bias introduced by the season of the year. Recovery, defined as reaching a weight-for-height z score > -2, and relapse or death were the primary outcomes. The rate of weight gain and the prevalence of fever, cough, and diarrhea were the secondary outcomes.
                Children who received home-based therapy with RUTF were more likely to achieve a weight-for-height z score > -2 than were those who received standard therapy (79% compared with 46%; P < 0.001) and were less likely to relapse or die (8.7% compared with 16.7%; P < 0.001). Children who received home-based therapy with RUTF had greater rates of weight gain (3.5 compared with 2.0 g . kg(-1) . d(-1); difference: 1.5; 95% CI: 1.0, 2.0 g . kg(-1) . d(-1)) and a lower prevalence of fever, cough, and diarrhea than did children who received standard therapy.
                Home-based therapy with RUTF is associated with better outcomes for childhood malnutrition than is standard therapy. Standard nutritional treatment of moderate acute malnutrition (MAM) relies on fortified blended flours though their importance to treat this condition is a matter of discussion. With the newly introduced World Health Organization growth standards, more children at an early stage of malnutrition will be treated following the dietary protocols as for severe acute malnutrition, including ready-to-use therapeutic food (RUTF). We compared the effectiveness of RUTF and a corn/soy-blend (CSB)-based pre-mix for the treatment of MAM in the supplementary feeding programmes (SFPs) supported by Médecins Sans Frontières, located in the Zinder region (south of Niger). Children measuring 65 to <110 cm, newly admitted with MAM [weight-for-height (WHM%) between 70% and <80% of the NCHS median] were randomly allocated to receive either RUTF (Plumpy'Nut®, 1000 kcal day(-1)) or a CSB pre-mix (1231 kcal day(-1)). Other interventions were similar in both groups (e.g. weekly family ration and ration at discharge). Children were followed weekly up to recovery (WHM% ≥ 85% for 2 consecutive weeks). In total, 215 children were recruited in the RUTF group and 236 children in the CSB pre-mix group with an overall recovery rate of 79.1 and 64.4%, respectively (p < 0.001). There was no evidence for a difference between death, defaulter and non-responder rates. More transfers to the inpatient Therapeutic Feeding Centre (I-TFC) were observed in the CSB pre-mix group (19.1%) compared to the RUTF group (9.3%) (p = 0.003). The average weight gain up to discharge was 1.08 g kg(-1) day(-1) higher in the RUTF group [95% confidence interval: 0.46-1.70] and the length of stay was 2 weeks shorter in the RUTF group (p < 0.001). For the treatment of childhood MAM in Niger, RUTF resulted in a higher weight gain, a higher recovery rate, a shorter length of stay and a lower transfer rate to the I-TFC compared to a CSB pre-mix. This might have important implications on the efficacy and the quality of SFPs. Standard therapy for severe acute malnutrition (SAM) is home-based therapy with ready-to-use therapeutic food (RUTF) containing 25% milk. In an effort to lower the cost of RUTF and increase availability, some have suggested that a portion of milk be replaced with soy. This trial was designed to determine whether treating children with SAM with 10% milk RUTF containing soy would result in a similar recovery rate compared with the 25% milk RUTF. This was a randomized, double-blind, controlled, clinical, quasi-effectiveness trial of isoenergetic amounts of 2 locally produced RUTF to treat SAM in Malawi among children aged 6-59 mo. A total of 1874 children were enrolled. Children were assessed every fortnight and participated in the study until they clinically recovered or received 8 wk of treatment. The primary outcome was recovery (weight-for-height Z score > -2 and no edema). Secondary outcomes were rates of weight and height gain. Survival analysis was used to compare the recovery rates. Recovery among children receiving 25% milk RUTF was greater than children receiving 10% milk RUTF, 64% compared with 57% after 4 wk, and 84% compared with 81% after 8 wk (P < 0.001). Children receiving 25% milk RUTF also had higher rates of weight and height gain compared with children receiving 10% milk RUTF. Treating children with SAM with 10% milk RUTF is less effective compared with treatment with the standard 25% milk RUTF. These findings also emphasize that clinical evidence should be examined before recommending any changes to the formulation of RUTF.
Given the limited evidence base currently available, it is not possible to reach definitive conclusions regarding differences in clinical outcomes in children with severe acute malnutrition who were given home-based ready-to-use therapeutic food (RUTF) compared to the standard diet, or who were treated with RUTF in different daily amounts or formulations. For this reason, either RUTF or flour porridge can be used to treat children at home depending on availability, affordability and practicality. Well-designed, adequately powered pragmatic randomised controlled trials of HIV-uninfected and HIV-infected children with severe acute malnutrition are needed.