Uncomplicated Severe Acute Malnutrition Research Articles

Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial

IntroductionHigh-quality evidence is crucial for guiding effective humanitarian responses, yet conducting rigorous research, particularly randomised controlled trials, in humanitarian crises remains challenging. The TISA (“traitement intégré de la sous-nutrition aiguë”) trial aimed to evaluate the impact of a Water, Sanitation and Hygiene (WASH) intervention on the standard national treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6–59 months. Implemented in two northern Senegalese regions from December 22, 2021, to February 20, 2023, the trial faced numerous challenges, which this paper explores along with the lessons learned.MethodsThe study utilised trial documentation, including field reports, meeting minutes, training plans, operational monitoring data and funding proposals, to retrace the trial timeline, identify challenges and outline implemented solutions. Contributions from all TISA key staff—current and former, field-based and headquarters—were essential for collecting and interpreting information. Challenges were categorised as internal (within the TISA consortium) or external (broader contextual issues).ResultsThe TISA trial, executed by a consortium of academic, operational, and community stakeholders, enrolled over 2000 children with uncomplicated SAM across 86 treatment posts in a 28,000 km2 area. The control group received standard outpatient SAM care, while the intervention group also received a WASH kit and hygiene promotion. Initially planned to start in April 2019 for 12 months, the trial faced a 30-month delay and was extended to 27 months due to challenges like the COVID-19 pandemic, national strikes, health system integration issues and weather-related disruptions. Internal challenges included logistics, staffing, data management, funding and aligning diverse stakeholder priorities.Discussion and conclusionDespite these obstacles, the trial concluded successfully, underscoring the importance of tailored monitoring, open communication, transparency and community involvement. Producing high-quality evidence in humanitarian contexts demands extensive preparation and strong coordination among local and international researchers, practitioners, communities, decision-makers and funders from the study’s inception.Trial registrationClinicaltrials.gov NCT04667767.

Clinical and biochemical responses to treatment of uncomplicated severe acute malnutrition: a multicenter observational cohort from the OptiDiag study

BackgroundSevere acute malnutrition (SAM) can be diagnosed using weight-for-height Z-score (WHZ) and/or mid-upper arm circumference (MUAC). Although some favor using MUAC alone, valuing its presumed ability to identify children at greatest need for nutritional care, the functional severity and physiological responses to treatment in children with varying deficits in WHZ and MUAC remain inadequately characterized. ObjectiveWe aimed to compare clinical and biochemical responses to treatment in children with 1) both low MUAC and low WHZ, 2) low MUAC-only, and 3) low WHZ-only. MethodsA multicenter, observational cohort study was conducted in children aged 6–59 mo with nonedematous, uncomplicated SAM in Bangladesh, Burkina Faso, and Liberia. Anthropometric measurements and critical indicators were collected 3 times during treatment; metrics included clinical status, nutritional status, viability, and serum leptin, a biomarker of mortality risk in SAM. ResultsChildren with combined MUAC and WHZ deficits had greater increases in leptin levels during treatment than those with low MUAC alone, showing a 34.4% greater increase on the second visit (95% confidence interval [CI]: 7.6%, 43.6%; P = 0.02) and a 34.3% greater increase on the third visit (95% CI: 13.2%, 50.3%; P = 0.01). Similarly, weight gain velocity was higher by 1.56 g/kg/d in the combined deficit group (95% CI: 0.38, 2.75; P = 0.03) compared with children with low MUAC-only. Children with combined deficits had higher rates of iron deficiency and wasting while those with low WHZ alone and combined deficits had higher rates of tachypnea and pneumonia during treatment. ConclusionsGiven the comparable treatment responses of children with low WHZ alone and those with low MUAC alone, and the greater vulnerability at admission and during treatment in those with combined deficits, our findings support retaining WHZ as an independent diagnostic and admission criterion of SAM, alongside MUAC.This trial was registered at www.clinicaltrials.gov/study/NCT03400930 as NCT03400930.

Time to recovery and its predictors among children aged 6-59 months having uncomplicated severe acute malnutrition attending an outpatient therapeutic program in Northeast Ethiopia: prospective cohort study.

There are insufficient data regarding the variables influencing recovery times, despite the accessible outpatient therapy program (OTP) bringing services for treating severe acute malnutrition (SAM) closer to the community. Therefore, this study aimed to identify the factors influencing the recovery duration in children with uncomplicated SAM between the ages of 6 and 59 months who were attending an OTP in North Wollo, northern Ethiopia. From February 2021 to July 2021, 356 children, ages 6-59 months, enrolled in a facility-based prospective cohort study. An interviewer administered a semi-structured questionnaire once a week to acquire anthropometric measures. The data were imported into Stata version 14.2 for analysis from EPI data entry version 4.6.06. The time to recovery for each attribute was determined using a log-rank test, a survival curve, and a Kaplan-Meier estimate of the median time to recovery. The Cox Proportional-Hazards Model was used to identify independent predictors of recovery time; statistical significance was indicated at 95% CI and a p-value of 0.05. With a recovery rate of 74.7%, the median recovery period was 56 days. Frequency of growth monitoring and promotion (GMP) service utilization [AHR = 1.622 (95% CI: 1.052-2.130)], cough [AHR = 0.385 (95% CI: 0.176-0.843)], maternal delivery at health center [AHR = 1.448 (95% CI: 1.023-2.050)], and maternal literacy [AHR = 1.445 (95% CI: 1.019-2.058)] were determinants of time to recovery. The median recovery period was 56 days with a recovery rate of 74.7%. Regular utilization of GMP services, maternal delivery at the health center, and cough at admission were independent predictors for this study. As a result, there should be a greater emphasis on the importance of girls' (future mothers') education and nutrition counseling, particularly the integration of GMP service components into institutional delivery/for girls/women who have received little education on how to improve time to recovery and the success of the OTP.

Predictors of time to recovery from uncomplicated severe acute malnutrition among children in eastern Ethiopia.

Managing severe acute malnutrition (SAM) involves an outpatient therapeutic program (OTP), targeting more than 80% of SAM children where the quality of primary healthcare remains poor. Treatment success and recovery from SAM remain poor and could be affected by many factors, where such evidence is limited in East Hararghe. This study assessed the predictors of time to recovery from SAM in eastern Ethiopia. A retrospective cohort study was conducted on 402 records of SAM children under 5 years of age enrolled on OTP at 12 health posts retrieved from 2020 to 2021. We used the Kaplan-Meir estimate along with the p-value of the log-rank test and the survival curve to compare the time to recovery across categories. A multivariable Cox proportional hazard model was fitted to identify predictors of time to recovery from SAM. A p-value below 0.05 was used to declare statistical significance. A total of 402 records were reviewed, and the cure rate from SAM was 89.6% [95% confidence interval (CI), 87-93]. Moreover, a death rate of 0.7%, a default rate of 9.5%, and a non-responder rate of 0.2% were obtained with a median length of stay of 7 weeks. The median time to recovery was significantly shorter for children from shorter distances from OTP sites with edema, amoxicillin, (p < 0.05). Edema at admission [adjusted hazard ratio (AHR) = 1.74; 95% CI: 1.33-2.29], without diarrhea (AHR = 1.51; 95% CI: 1.18-1.94), taking amoxicillin (AHR = 1.55; 95% CI: 1.19-2.02), shorter travel time to the OTP site (AHR = 1.44; 95% CI: 1.13-1.85), breastfeeding (AHR = 1.60; 95% CI: 1.27-2.02), adequacy of ready-to-use therapeutic food (RUTF) (AHR = 1.22; 95% CI: 0.90-1.65), and new admission (AHR = 1.62; 95% CI: 0.84-3.10) were important predictors of recovery from SAM. Recovery from SAM was found to be acceptable in comparison with the Sphere Standards and is predicted by edema, diarrhea, distance from the OTP site, amoxicillin, and RUTF adequacy. These allow for focused interventions that address the identified factors for better recovery from SAM.

Effectiveness of a nonweight-based daily dosage of ready-to-use therapeutic food in children suffering from uncomplicated severe acute malnutrition: A nonrandomized, noninferiority analysis of programme data in Afghanistan.

Severe acute malnutrition (SAM) remains a major global public health problem. SAM cases are treated using ready-to-use therapeutic food (RUTF) at a dosage of ∼200 kcal/kg/day per the standard treatmentprotocol (STD). Emerging evidence on simplifications to the standard protocol, which among other adaptations, includes reducing the daily RUTF dosage, indicates that it is effective and safe for treating children with SAM. In response to a foreseen stock shortage of RUTF, the government of Afghanistan endorsed the temporary use of a modified treatment protocol in which the daily RUTF dosage was prescribed at 1000 kcal/day (irrespective of body weight) until the child achieved moderate acute malnutrition status (weight-for-heightz-score ≥ -3 or mid-upper arm circumference [MUAC] ≥ 115 mm), at which point 500 kcal/day was prescribed until cured (modified treatment protocol [MTP]). In this paper, we report the results of this nonweight-based daily RUTF dosage experience. Data of 2042 children with SAM, treated using either the STD protocol (n = 269) or the MTP protocol (n = 1773) from August 2019 to March 2021 in five provinces, were analyzed. The per-protocol analyses confirmed noninferiority of MTP protocol when compared to STD protocol for recovery rate [93.3% vs. 90.2%; ∆ (95% confidence interval,CI) = 3.1 (-0.9; 7.2) %] and length-of-stay [82.6 vs. 75.6 days; ∆ (95%CI) = 6.9 (3.3; 10.5) days], considering the margin of noninferiority of -10% and +14 days, respectively. Weight gain velocity was smaller in theMTP protocol group than in the STD protocol group [3.7 (1.7) vs. 5.2 (2.9) g/kg/day; ∆ (95%CI) = -1.5 (-1.8, -1.2); p < 0.001]. The STD group had a significantly higher mean than the MTP group for absolute MUACgain [∆ (95%CI) = 1.7 (1.0; 2.3) mm; p < 0.001] and the MUAC velocity [∆ (95%CI) = 0.29 (0.20; 0.37) mm/week; p < 0.001]. Our results confirm the noninferiority of a nonweight-based daily dosage and support the endorsement of this modification as an alternative to the standard protocol in resource-constrained contexts.

Cost-effectiveness of severe acute malnutrition treatment delivered by community health workers in the district of Mayahi, Niger

BackgroundA non-randomized controlled trial, conducted from June 2018 to March 2019 in two rural communes in the health district of Mayahi in Niger, showed that including community health workers (CHWs) in the treatment of severe acute malnutrition (SAM) resulted in a better recovery rate (77.2% vs. 72.1%) compared with the standard treatment provided solely at the health centers. The present study aims to assess the cost and cost-effectiveness of the CHWs led treatment of uncomplicated SAM in children 6–59 months compared to the standard national protocol.MethodsTo account for all relevant costs, the cost analysis included activity-based costing and bottom-up approaches from a societal perspective and on a within-trial time horizon. The cost-effectiveness analysis was conducted through a decision analysis network built with OpenMarkov and evaluated under two approaches: (1) with recovery rate and cost per child admitted for treatment as measures of effectiveness and cost, respectively; and (2) assessing the total number of children recovered and the total cost incurred. In addition, a multivariate probabilistic sensitivity analysis was carried out to evaluate the effect of uncertainty around the base case input data.ResultsFor the base case data, the average cost per child recovered was 116.52 USD in the standard treatment and 107.22 USD in the CHWs-led treatment. Based on the first approach, the CHWs-led treatment was more cost-effective than the standard treatment with an average cost per child admitted for treatment of 82.81 USD vs. 84.01 USD. Based on the second approach, the incremental cost-effectiveness ratio of the transition from the standard to the CHWs-led treatment amounted to 98.01 USD per additional SAM case recovered.ConclusionsIn the district of Mayahi in Niger, the CHWs-led SAM treatment was found to be cost-effective when compared to the standard protocol and provided additional advantages such as the reduction of costs for households.Trial registration: ISRCTN with ID 31143316. https://doi.org/10.1186/ISRCTN31143316

Effectiveness of Home-Based Administration of Ready to Use Therapeutic Formula (RUTF) in the Management of Severe Acute Malnutrition (SAM)

Objective: To evaluate the growth of children with uncomplicated Severe Acute Malnutrition (SAM) treated with Ready-to-Use Therapeutic Formula (RUTF) on an outpatient department basis. Methodology: This prospective observational study was conducted on 66 children at the Outpatient setting of the MCH Centre, Federal Government Polyclinic Hospital, Islamabad, Pakistan, from January 2023 to June 2023, after approval from the hospital’s ethical committee. Children aged 6-59 months suffering from severe acute malnutrition (SAM) were selected for nutritional rehabilitation with Ready-to-Use Therapeutic Formula (RUTF) after meeting the selection criteria defined by WHO. RUTF is a nutrient mixture formulated primarily for the therapy of severe acute malnutrition without complications. Results: The mean age of patients was 16.98±6.12 months. Out of 66 patients, 26 (39.3%) were male, and 40 (60.6%) were female. The mean weight before RUTF treatment was 6.53±1.21 kg, mean Height/Length was 71.65±7.01 cm, mean MUAC was 10.88±0.36 cm, mean BSR was 91.21±2.32 mg/dL, and mean weight after RUTF treatment was 9.17±1.53 kg. There was a significant difference in the weight of children after RUTF treatment (6.53±1.21 vs 9.17±1.53, p=0.0001) with no side effects. The weight increased after treatment with RUTF. Conclusion: According to WHO recommendations, we conclude that RUTF is helpful in enhancing weight gain in children with uncomplicated severe acute malnutrition under the age of five. RUTF

Comparison of biochemical and anthropometric parameters in complicated and uncomplicated severe acute malnutrition among children aged 6 to 59 months: a cross-sectional study

Aim: The frequency of severe acute malnutrition (SAM) is the highest in India. Although it should receive more attention, severe anemia is one of the comorbidities that increases mortality in children who are severely undernourished. In SAM children, the liver function test (LFT), kidney function test (KFT), and complete blood count (CBC) are deranged, but their correlation with the prognosis is not well defined. The aim was to describe the anthropometric assessment and biochemical profile of children with SAM. Methods: This cross-sectional cohort study was performed at the Departments of Paediatrics and Biochemistry at G.S.V.M. Medical College, Kanpur, and at the Department of Biotechnology at Amity University Rajasthan, Jaipur. One hundred and six patients with SAM were enrolled; 53 were grouped as complicated SAM (Group 1) (dehydration and severe dehydration) and 53 were diagnosed as non-complicated SAM (Group 2). Results: Group II had significantly higher mean values for height, weight, mid-upper arm circumference (MUAC), head circumference, and body mass index (BMI) for age percentile compared to Group I, with P-values of 0.001. Group I had a significantly lower level of hemoglobin (8.86 g/dL ± 2.21 g/dL) compared to Group II (10.0 g/dL ± 1.83 g/dL) with a P-value of 0.003. The difference in the frequency of anemia between the groups was statistically significant, with a P-value of 0.026. Anemia significantly increased the risk of complicated SAM with an odds ratio of 2.60 [95% confidence interval (CI), 1.07–6.31, P = 0.001]. Conclusions: This study suggests that there may be a significant relationship between anemia and the development of complications in high-risk children with SAM.

Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia

IntroductionCurrent formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota...

The Importance of Screening for Food Insecurity in Children with Sickle Cell Anemia: An Ancillary Study to the Severe Acute Malnutrition Feasibility Trial in Nigeria

Introduction Household food insecurity-lacking access to, or having uncertain access to, food that meets a person's dietary needs-is a longstanding problem in Nigeria that has continued to worsen in recent years. One of its most severe consequences is malnutrition, particularly affecting children due to their high nutrient demand coupled with higher energy expenditure. Even in high-income countries, such as the United States, many children with sickle cell anemia have lower weights and heights than their healthy peers. Due to their elevated nutrient requirements, children with sickle cell anemia may be at an even greater risk of malnutrition when faced with limited access to adequate food. The relationship between childhood food insecurity and malnutrition has been previously studied in younger children in Nigeria, but rarely in older children, and to our knowledge, never in older children with sickle cell anemia. We tested the hypothesis that there is a direct association between increased food insecurity and more severe malnutrition (lower body mass index [BMI] z-score) in older children with sickle cell anemia in Nigeria. Methods This was a planned analysis of the data of children enrolled in a feasibility trial for managing severe acute malnutrition in older children with sickle cell anemia in Nigeria (SAMS trial; #NCT03634488). In this study, children 5-12 years old with sickle cell anemia and uncomplicated severe acute malnutrition (BMI z-score &amp;lt;-3.0) were randomly assigned to receive either supplemental ready-to-use therapeutic food (RUTF) only or RUTF combined with moderate fixed-dose hydroxyurea therapy for 12 weeks. Baseline anthropometric data were obtained for each participant. Upon enrollment in the trial, the participants' caregivers completed the US Household Food Security Survey Module (HFSSM). Using the eight questions in the childhood portion of this standardized survey, we categorized the participants into three food security statuses: food security (0-1), low food security (2-4), and very low food security (5-8). Childhood food security scores were also measured as a continuous variable on a scale of 0-8, with higher scores indicating greater food insecurity. We constructed a linear regression model to estimate the association between childhood food insecurity and baseline BMI z-score. Results Data were collected between August 2021 and May 2022. The median age of the 108 participants in the study was 10.3 years (IQR 8.8-11.5). Most participants had low (55%) or very low (34%) food security. BMI z-score was not associated with categorical food security status (p=0.108). However, higher food insecurity as a continuous variable was associated with a lower BMI z-score (Pearson correlation -0.23, p=0.015; Figure 1). In a multivariable linear regression with sex, age at study entry, total hemoglobin, employment status, and head of household educational status, the childhood food insecurity score was negatively associated with the BMI z-score (Beta coefficient = -.05, p=0.047). Conclusions Our study reveals a high prevalence of food insecurity among older children with sickle cell anemia in Nigeria. Moreover, children experiencing higher food insecurity also exhibited more severe malnutrition, as evidenced by their lower BMI z-scores. Based on these results, we have started implementing food insecurity assessment as routine medical care in children with sickle cell anemia at multiple clinics in northern Nigeria. Children experiencing higher levels of food insecurity are referred to nutritional counseling, where they receive guidance on locally available nutrient-dense foods and preparation strategies. Figure 1.The predicted baseline body mass index z-score with 95% confidence intervals based on childhood food insecurity scores from a linear regression model of the participants in the SAMS trial.

Feasibility trial for the management of severe acute malnutrition in older children with sickle cell anemia in Nigeria

AbstractChildren with sickle cell anemia (SCA) living in Nigeria are at an increased risk of malnutrition, which contributes to increased morbidity and mortality. However, evidence-based guidelines for managing malnutrition in children with SCA are lacking. To address this gap, we conducted a multicenter, randomized controlled feasibility trial to assess the feasibility and safety of treating children with SCA aged from 5 to 12 years and having uncomplicated severe acute malnutrition (body mass index z score of <−3.0). Children with SCA and uncomplicated severe acute malnutrition were randomly allocated to receive supplemental ready-to-use therapeutic food (RUTF) with or without moderate-dose hydroxyurea therapy (20 mg/kg per day). Over a 6-month enrollment period, 3190 children aged from 5 to 12 years with SCA were evaluated for eligibility, and 110 of 111 children who were eligible were enrolled. During the 12-week trial, no participants withdrew or missed visits. One participant died of unrelated causes. Adherence was high for hydroxyurea (94%, based on pill counts) and RUTF (100%, based on the number of empty sachets returned). No refeeding syndrome event or hydroxyurea-related myelosuppression occurred. At the end of the trial, the mean change in body mass index z score was 0.49 (standard deviation = 0.53), and 39% of participants improved their body mass index z score to ≥−3.0. Our findings demonstrate the feasibility, safety, and potential of outpatient treatment for uncomplicated severe acute malnutrition in children with SCA aged from 5 to 12 years in a low-resource setting. However, RUTF sharing with household and community members potentially confounded the response to malnutrition treatment. This trial was registered at clinicaltrials.gov as #NCT03634488

Double-Blind Parallel Treatment Randomized Controlled Trial of Prebiotics' Efficacy for Children Experiencing Severe Acute Malnutrition in Southern Punjab, Pakistan.

The prevalence of malnutrition among children under five is alarmingly high in Pakistan. However, there are ready-to-use therapeutic foods (RUTF) available which may be used to treat children with severe acute malnutrition (SAM). This study aims to assess the efficacy of prebiotics as a synergistic additive to RUTF to enhance blood parameters and anthropometric measurements in children with uncomplicated SAM living in Southern Punjab, Pakistan. A double-blind parallel treatment randomized controlled trial was conducted on 204 children aged 6-59 months. Participants were randomized and allocated to the placebo (n = 102) or experimental arms (n = 102) in a 1:1 ratio. One group of children was provided with RUTF and 4 g prebiotics, while the other group was given RUTF and starch as a placebo. Participants recruited for both arms were given treatment for eight weeks, and then their biochemical and anthropometric outcomes were evaluated. A substantial difference between the mean weight, mid-upper-arm circumference, haemoglobin, haematocrit, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, and albumin was revealed. During the two-month follow-up phase of the trial, children who were enrolled in the treatment group gained about 20% of their initial weight (pre-study mean weight = 5.44 ± 1.35 kg; post-study mean weight = 6.53 ± 1.45 kg). The analysis showed a significant difference (p < 0.005) between the control and treatment groups for MUAC and complete blood counts. Conclusively, supplementation with RUTF and prebiotics has proven to be an efficient, effective, and safe therapy for children suffering from SAM to improve their growth and development indicators and reduce the dangers of malnutrition in comparison to RUTF alone.

Probiotics for children with uncomplicated severe acute malnutrition (PruSAM study): A randomized controlled trial in the Democratic Republic of Congo

BackgroundSevere acute malnutrition (SAM) contributes to nearly 1 million deaths annually worldwide, with diarrhea and pneumonia being the common morbidity associated with mortality. ObjectivesTo assess the effect of probiotics on diarrhea, pneumonia, and nutritional recovery in children with uncomplicated SAM. MethodsA randomized, double-blind, placebo-controlled study was conducted involving 400 children with uncomplicated SAM randomly assigned to ready-to-use therapeutic food (RUTF) either with (n = 200) or without (n = 200) probiotics. Patients received 1 mL daily dose of a blend of Lacticasebacillus rhamnosus GG and Limosilactobacillus reuteri DSM 17938 (dosage, 2 billion colony-forming units; 50:50) or placebo during 1 mo. They were simultaneously fed with the RUTF for 6 to 12 wk, depending on patients’ recovery rates. The primary outcome was the duration of diarrhea. Secondary outcomes included diarrheal and pneumonic incidence, nutritional recovery, and transfer to inpatient care rate. ResultsFor children with diarrhea, the number of days of disease was lower in the probiotic group (4.11; 95% CI: 3.37, 4.51) than that in the placebo group (6.68; 95% CI: 6.26, 7.13; P < 0.001). For children aged 16 mo or older, the risk of diarrhea was lower in the probiotic group (75.6%; 95% CI: 66.2, 82.9) than that in the placebo group (95.0%; 95% CI: 88.2, 97.9; P < 0.001), but no significant difference of the risk for the youngest. In the probiotic group, nutritional recovery happened earlier: at the 6th wk, 40.6% of the infants were waiting for nutritional recovery, contrasting with 68.7% of infants in the placebo group; but the nutritional recovery rate at the 12th wk was similar between the groups. Probiotics had no effect on pneumonic incidence and transfer to inpatient care. ConclusionsThis trial supports using probiotics for the treatment of children with uncomplicated SAM. Its effect on diarrhea could positively affect nutritional programs in resource-limited settings.This trial was registered https://pactr.samrc.ac.za as PACTR202108842939734.

Optimising the dosage of ready-to-use therapeutic food in children with uncomplicated severe acute malnutrition in the Democratic Republic of the Congo: a non-inferiority, randomised controlled trial

Current standard management of severe acute malnutrition uses ready-to-use therapeutic food (RUTF) at a single weight-based calculation resulting in an increasing amount of RUTF provided to the family as the child's weight increases during recovery. Using RUTF at a gradually reduced dosage as the child recovers could reduce costs while achieving similar growth response. We conducted an open-label, non-inferiority, randomised controlled trial in the Democratic Republic of the Congo. Children aged 6-59 months with a mid-upper-arm circumference (MUAC) of less than 115mm or a weight-for-height z-score (WHZ) of less than-3 or bipedal oedema and without medical complication were randomly assigned (1:1 ratio) using a specially developed software and random blocks (size was kept confidential), to either the current standard treatment (increasing the RUTF amount with increasing weight) or the OptiMA strategy (decreasing the RUTF dose with increasing weight and MUAC). The main endpoint was proportion of children who achieved recovery over the 6 months follow up period, as defined as meeting the following criteria for two consecutive weeks after a minimum of 4 weeks' treatment: axillary temperature less than 37.5°C, no bipedal oedema, and anthropometric improvement (either MUAC 125mm or greater or WHZ-1.5 or higher). We performed analyses on the intention-to-treat (ITT) (all children) and per-protocol populations (participants who had a minimum prescription of 4 weeks' RUTF, received at least 90% of the total amount of RUTF they were supposed to receive as per the protocol, and had a maximum interval of 6 weeks between any two visits in the 6-month follow-up). The non-inferiority margin was 10%. This trial is registered at ClinicalTrials.gov, and is now closed NCT03751475. Between July 22, 2019, and January 20, 2020, 491 children were randomly assigned, of whom 482 were analysed (240 in the standard group and 242 in the OptiMA group). In the ITT analysis, 234 (98%) children in the standard group and 231 (96%) children in OptiMA recovered (difference 2.0%, 95% CI-2.0% to 6.4%). In the PP analysis, 234 (98%) children in the standard group and 228 (97%) in OptiMA recovered (difference 1.3%, 95% CI-2.3% to 5.1%). Sensitivity analyses applying the same anthropometric recovery criteria to each group also showed non-inferiority of the OptiMA strategy in ITT and PP analysis. This non-inferiority trial treating uncomplicated children with MUAC of less than 115mm or a WHZ of less than-3 or bipedal oedema with decreasing RUTF dose as MUAC and weight increase demonstrated non-inferiority compared to the standard protocol in a highly food-insecure context in the Democratic Republic of the Congo. These findings add evidence on the safety of RUTF dose reduction with significant RUTF cost savings. Innocent Foundation and European Civil Protection and Humanitarian Aid Operations. For the French translation of the abstract see Supplementary Materials section.

Predictors of time to recovery from uncomplicated severe acute malnutrition among 6–59 months children treated in out patient treatment in health posts of Nagele Arsi district: a retrospective cohort study

BackgroundAccess to outpatient therapeutic feeding programs (OTP) for all children who have uncomplicated severe acute malnutrition (SAM) remains a global public health priority. Identifying predictors that determine time-to-recovery from severe acute malnutrition optimize therapeutic success. However, reliable evidence on the determinants of time to recovery at health posts was not available in Nagele Arsi district of South Ethiopia.ObjectiveThis study was aimed to identify determinants of time-to-recovery from uncomplicated SAM among children aged (6–59) months treated at an OTP in health posts of Nagele Arsi district, Southern Ethiopia.MethodsInstitutional based retrospective cohort study was conducted among 357 children treated in Negele Arsi district from July1, 2018 to June 30, 2020. The children were selected using simple random sampling from 20 health posts. SAM treatment outcomes were compared against international SPHERE standards. The average time-to-recovery was estimated using Kaplan-Meier survival curve and the independent predictors of time to recovery were determined using multivariable Cox-proportional hazard model. The strength of the association was done using adjusted hazard ratio (AHR) with 95% confidence intervals. Statistical significance was declared at p value < 0.05. The results were presented by text, tables and figures.ResultA total of 284 (79.6%) children recovered during follow up. The mean weight gain for recovered children was 4.7 + 2.4 g/kg/day. The median time-to-recovery was 44 days 95% CI (42.7–45.3). Children who received Amoxicillin, AHR =2.574, 95% CI (1.879–3.525); de-wormed, AHR = 1.519, 95% CI (1.137–2.031); received Vitamin A, AHR = 2.518, 95% CI, (1.921–3.301) and new admissions, AHR = 1.823, 95%CI, (1.224–2.715) were more likely to recover. However, those who admitted with non-edema, AHR = 0.256, 95% CI, (0.189–0.346); had cough at admission, AHR = 0.513, 95 CI, (0.366–0.719) and had diarrhea at admission AHR = 0.5, 95% CI, 0.5 (0.350–0.712) were less likely to recover.Conclusion and recommendationThe recovery rate was within the acceptable ranges of International Sphere Standards. Those children who had cough and diarrhea should be given due attention from health extension workers and program planners. Appropriate provision of routine medication and timely intervention of co-morbidity are needed to increase chance of early recovery.

Cost-effectiveness of monthly follow-up for the treatment of uncomplicated severe acute malnutrition: An economic evaluation of a randomized controlled trial.

Severe acute malnutrition (SAM) is a major source of mortality for children in low resource settings. Alternative treatment models that improve acceptability and reduce caregiver burden are needed to improve treatment access. We assessed costs and cost-effectiveness of monthly vs. weekly follow-up (standard-of-care) for treating uncomplicated SAM in children 6-59 months of age. To do so, we conducted a cost-effectiveness analysis of a cluster-randomized trial of treatment for newly-diagnosed uncomplicated SAM in northwestern Nigeria (clinicaltrials.gov ID NCT03140904). We collected empirical costing data from enrollment up to 3 months post-discharge. We quantified health outcomes as the fraction of children recovered at discharge (primary cost-effectiveness outcome), the fraction recovered 3 months post-discharge, and total DALYs due to acute malnutrition. We estimated cost-effectiveness from both provider and societal perspectives. Costs are reported in 2019 US dollars. Provider costs per child were $67.07 (95% confidence interval: $64.79, $69.29) under standard-of-care, and $78.74 ($77.06, $80.66) under monthly follow-up. Patient costs per child were $21.04 ($18.18, $23.51) under standard-of-care, and $14.16 ($12.79, $15.25) under monthly follow-up. Monthly follow-up performed worse than standard-of-care for each health outcome assessed and was dominated (produced worse health outcomes at higher cost) by the standard-of-care in cost-effectiveness analyses. This result was robust to statistical uncertainty and to alternative costing assumptions. These findings provide evidence against monthly follow-up for treatment of uncomplicated SAM in situations where weekly follow-up of patients is feasible. While monthly follow-up may reduce burdens on caregivers and providers, other approaches are needed to do so while maintaining the effectiveness of care.

Supplementary suckling technique in infants less than 6 months of age with uncomplicated severe acute malnutrition: a prospective hospital-based study in armed conflict Yemen

BackgroundGlobally 3.8 million of children under 6 month of age are severely wasted. In Yemen, around 20% of children under 6 months were affected by malnutrition during the armed conflict in the last 7 years. Supplementary suckling may reestablish exclusive breastfeeding in infant less than 6 months of age with Severe Acute Malnutrition (SAM). This study aimed to determine the outcomes of employing supplementary suckling technique in treatment of uncomplicated SAM infants in a conflict-affected community.MethodsA prospective hospital-based study was carried out between January to April 19th, 2020 among randomly selected infants less than 6 months of age with SAM following breastfeeding failure. Infants’ anthropometric indices were daily measured and recorded. Supplementary sulking technique was used in management with high or low protein milk-based formula supplement. Outcome was recorded as cured, died, defaulter or in nonrecovery state.ResultsIn this study 108 infants were enrolled with a median (IQR) age of 4 (2.5-5) years and a male: female ratio of 1.4:1. After treatment, 80.6% recovered to cure, 12% defaulters, 6% died, and 2% did not respond to treatment Thirty-four infants (38.8%) gained weight with significantly increased median weight and median weight-for-age z score. The median (IQR) duration of treatment was 9 (7.5-14) days. The means of age and weight-for-length z score were correlated (r = − 0.22, p = 0.025). Duration of treatment was a predictor of outcome (OR = 1.71, 95% CI = 0.05-0.62, p < 0.001).ConclusionSupplementary suckling technique for feeding infant with SAM aged less than 6 months had a positive impact on anthropometric indices with high cure rate. The younger the infant and the longer the duration of treatment, the better the outcome.

Outpatient Therapeutic Programme for Malnourished Children

Outpatient therapeutic programme (OTP) is one of the approaches of community-based management of acute malnutrition (CMAM), which includes community engagement and mobilization for outpatient management of uncomplicated severe acute malnutrition (SAM) children 6–59 months with good appetite, by providing them by home-based treatment as Ready-to-use Therapeutic Food (RUTF) and routine medical treatment. Around 85-90% of children with SAM are successfully treated at home in OTP, by attending regular intervals until they recover. OTP is currently used to achieve rapid recovery from SAM, it provides services of SAM management closer to the community at primary health care centers, where uncomplicated SAM children receive different amount of RUTF as Plumpy'Nut sachets according to their body weight.

Evaluation of the community-based outpatient therapeutic feeding program implementation for managing children with severe acute malnutrition in Northwest Ethiopia: A mixed-method evaluation protocol.

Community-based outpatient therapeutic feeding program (C-OTP) in Ethiopia has been launched to manage uncomplicated severe acute malnutrition (SAM) by trained Health Extension Workers (HEWs). This program is believed to be the most effective strategy for reaching a large group of children suffering from SAM in rural and disadvantaged communities. Nonetheless, poor treatment outcomes, notably mortality and prolonged recovery time, become pressing public health problems, which could be a result of suboptimal implementation and poor service quality. To evaluate the implementation of C-OTP for managing uncomplicated severe acute malnutrition in the Central Gondar Zone. Multiple studies involving both qualitative and quantitative will be conducted. Availability of essential drugs and equipment, acceptability of the program by mothers/caregivers, health extension workers' compliance to the treatment protocol, and treatment outcome will be assessed employing different methods. Likewise, knowledge of health extension workers about SAM diagnosis and management and their skills to diagnose and manage uncomplicated malnutrition will be determined. Health extension workers, mothers/caregivers, supervisors, and healthcare administrators will be enrolled in the study. Besides, children's medical records registered between 2017 and 2020 will be reviewed to determine the treatment outcome. The data will be collected using pretested self-administered and face-to-face interviewer-administered questionnaires. Similarly, focus group discussions (FGDs), in-depth interviews, and observation checklists will be applied. Binary logistic regression analysis will be conducted, while the qualitative data will be analyzed using thematic content analysis. Severe acute malnutrition is a public health problem that remains the underlying cause for over half of under-five mortality in Ethiopia. As a result, community-based therapeutic care has been launched in the country to address these problems and maximize population-level impact by improving treatment coverage, access, and cost-effectiveness. Despite its achievement, the program has been threatened with unfavourable treatment outcomes and a shortfall of resources. Hence, this implementation evaluation study will also identify gaps between healthcare systems and service users. The output will help programmers pass evidence-based and sound decisions to tackle the key barriers.

Outpatient Therapeutic Programme for Malnourished Children

Outpatient therapeutic programme (OTP) is one of the approaches of community-based management of acute malnutrition (CMAM), which includes community engagement and mobilization for outpatient management of uncomplicated severe acute malnutrition (SAM) children 6–59 months with good appetite, by providing them by home-based treatment as Ready-to-use Therapeutic Food (RUTF) and routine medical treatment. Around 85-90% of children with SAM are successfully treated at home in OTP, by attending regular intervals until they recover. OTP is currently used to achieve rapid recovery from SAM, it provides services of SAM management closer to the community at primary health care centers, where uncomplicated SAM children receive different amount of RUTF as Plumpy'Nut sachets according to their body weight.