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Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally. A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints. Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230). The trial is registered at ISRCTN, trial number ISRCTN30393230.

Recent data suggest that case fatality from severe acute malnutrition (SAM) in India may be lower than the 10%-20% estimated by the World Health Organization (WHO). A contemporary quantification of mortality and recovery from acute malnutrition in Indian community settings is essential to inform policy regarding the benefits of scaling up prevention and treatment programmes. We conducted a cohort study using data collected during a recently completed cluster-randomised controlled trial in 120 geographical clusters with a total population of 121,531 in rural Jharkhand and Odisha, eastern India. Children born between October 1, 2013, and February 10, 2015, and alive at 6 months of age were followed up at 9, 12, and 18 months. We measured the children's anthropometry and asked caregivers whether children had been referred to services for malnutrition in the past 3 months. We determined the incidence and prevalence of moderate acute malnutrition (MAM) and SAM, as well as mortality and recovery at each follow-up. We then used Cox-proportional models to estimate mortality hazard ratios (HRs) for MAM and SAM. In total, 2,869 children were eligible for follow-up at 6 months of age. We knew the vital status of 93% of children (2,669/2,869) at 18 months. There were 2,704 children-years of follow-up time. The incidence of MAM by weight-for-length z score (WLZ) and/or mid-upper arm circumference (MUAC) was 406 (1,098/2,704) per 1,000 children-years. The incidence of SAM by WLZ, MUAC, or oedema was 190 (513/2,704) per 1,000 children-years. There were 36 deaths: 12 among children with MAM and six among children with SAM. Case fatality rates were 1.1% (12/1,098) for MAM and 1.2% (6/513) for SAM. In total, 99% of all children with SAM at 6 months of age (227/230) were alive 3 months later, 40% (92/230) were still SAM, and 18% (41/230) had recovered (WLZ ≥ -2 standard deviation [SD]; MUAC ≥ 12.5; no oedema). The adjusted HRs using all anthropometric indicators were 1.43 (95% CI 0.53-3.87, p = 0.480) for MAM and 2.56 (95% CI 0.99-6.70, p = 0.052) for SAM. Both WLZ < -3 and MUAC ≥ 11.5 and < 12.5 were associated with increased mortality risk (HR: 3.33, 95% CI 1.23-8.99, p = 0.018 and HR: 3.87, 95% CI 1.63-9.18, p = 0.002, respectively). A key limitation of our analysis was missing WLZ or MUAC data at all time points for 2.5% of children, including for two of the 36 children who died. In rural eastern India, the incidence of acute malnutrition among children older than 6 months was high, but case fatality following SAM was 1.2%, much lower than the 10%-20% estimated by WHO. Case fatality rates below 6% have now been recorded in three other Indian studies. Community treatment using ready-to-use therapeutic food may not avert a substantial number of SAM-related deaths in children aged over 6 months, as mortality in this group is lower than expected. Our findings strengthen the case for prioritising prevention through known health, nutrition, and multisectoral interventions in the first 1,000 days of life, while ensuring access to treatment when prevention fails.

In this randomized, controlled trial involving 2767 Malawian children with severe acute malnutrition, use of antibiotics (for the first 7 days) with the initiation of therapeutic food reduced mortality and increased weight gain. The contribution of severe acute malnutrition to the overall burden of childhood morbidity and mortality is enormous, with more than 20 million children with severe wasting worldwide, 1 an untold number with kwashiorkor, and case fatality rates among hospitalized children that are as high as 50%. 1 , 2 For decades, the primary management for severe acute malnutrition was based on inpatient rehabilitation with fortified milk formulas. 3 However, international consensus guidelines now recommend the use of ready-to-use therapeutic food (RUTF) — usually a fortified spread consisting of peanut paste, milk powder, oil, sugar, and a micronutrient supplement — in outpatient settings as the . . .

Background: From the 1950s to the mid-1970s, United Nations (UN) agencies were focused on protein malnutrition as the major worldwide nutritional problem. The goal of this review is to examine this era of protein malnutrition, the reasons for its demise, and the aftermath. Summary: The UN Protein Advisory Group was established in 1955. International conferences were largely concerned about protein malnutrition in children. By the early 1970s, UN agencies were ringing the alarm about a ‘protein gap'. In The Lancet in 1974, Donald McLaren branded these efforts as ‘The Great Protein Fiasco', declaring that the ‘protein gap' was a fallacy. The following year, John Waterlow, the scientist who led most of the efforts on protein malnutrition, admitted that a ‘protein gap' did not exist and that young children in developing countries only needed sufficient energy intake. The emphasis on protein malnutrition waned. It is recently apparent that quality protein and essential amino acids are missing in the diet and may have adverse consequences for child growth and the reduction of child stunting. Key Messages: It may be time to re-include protein and return protein malnutrition in the global health agenda using a balanced approach that includes all protective nutrients.

Background Malnutrition is a significant risk factor for postoperative complications in patients undergoing colorectal cancer surgery. Although current guidelines recommend preoperative immunonutrition for malnourished patients, its clinical benefit remains controversial. Our previous randomized clinical trial assessing immunonutrition in unselected colon cancer patients showed no reduction in infectious complications. This study aims to evaluate the efficacy of preoperative immunonutrition in reducing postoperative complications in malnourished patients undergoing colorectal cancer surgery. Methods This multicenter, parallel, superiority, randomized clinical trial will include patients with primary colorectal cancer and Nutritional Risk Screening (NRS) 2002 score of 3–5 from eight participating institutions. Patients will be randomly assigned (1:1) to receive either preoperative immunonutrition with oral nutritional supplements (400 mL/day) containing arginine and ω-3 fatty acids for 7 days before surgery (intervention group) or a standard preoperative diet alone (control group). The primary endpoint is the rate of infectious complications within 30 days postoperatively. Secondary endpoints include overall postoperative complication rate, length of hospital stay, perioperative body weight changes, and alterations in nutritional and immune response markers (serum transferrin, prealbumin, albumin, cytokines, prostaglandin E2, high-sensitivity C-reactive protein). A sample size of 176 patients (88 per arm) was determined to detect a significant reduction in infectious complications from 30% (control) to 12% (intervention), with 80% power and a two-sided α of 0.05. Discussion This study addresses a critical gap in evidence by focusing on nutritionally at-risk colorectal cancer patients. Unlike previous trials on unselected populations, this trial specifically evaluates the impact of immunonutrition in a high-risk group in which nutritional optimization may yield clinical benefits. Additionally, the multicenter design enhances generalizability. If preoperative immunonutrition effectively reduces postoperative complications, it could support a targeted nutritional intervention strategy for malnourished colorectal cancer patients, optimizing perioperative care and potentially reducing the healthcare burden. Trial registration Clinical Research Information Service KCT0008382. Registered on April 25, 2023.

The role of routine antibiotic use in the treatment of severe acute malnutrition is unclear. In this randomized, placebo-controlled trial in Niger, amoxicillin did not significantly improve nutritional recovery in children with severe acute malnutrition. Severe acute malnutrition affects approximately 19 million children under 5 years of age worldwide and contributes substantially to mortality and the disease burden among children. 1 To reduce the risk of death from severe acute malnutrition, specialized nutritional and medical intervention is required. Bacterial infection can complicate advanced cases of severe acute malnutrition, 2 – 9 and the risk of nosocomial infection in inpatient settings can be high. Therefore, in 1999, when all children with severe acute malnutrition were treated as inpatients, the World Health Organization (WHO) recommended routine use of broad-spectrum antibiotics for the management of severe acute malnutrition, irrespective of clinical . . .

Poor infant and young child feeding (IYCF) practices are major determinants of chronic malnutrition. The main objective of this study was to assess the impact of a nutrition education (NE) programme aimed at promoting improved IYCF behaviours in combination with an agriculture intervention on children’s dietary diversity and nutritional status. From 2012 to 2014, a cluster randomised trial was rolled out in Cambodia in the context of an agriculture and nutrition project of the FAO of the UN. The cross-sectional baseline study was carried out in sixteen pre-selected communes in 2012. Restricted randomisation allotted the communes to either intervention (NE and agriculture intervention) or comparison arms (agriculture intervention only). The impact survey was conducted as a census in all FAO project villages in 2014. Caregivers of children aged 0–23 months were interviewed using standardised questions on socio-economic status and dietary diversity (24-h recall). Anthropometric measurements were taken. A difference-in-differences model was applied. The sample comprised 743 households with children ≥6 months of age at baseline and 921 at impact. After 1 year of NE, 69 % of the intervention households reported to have participated in the NE. Estimated mean child dietary diversity was significantly different at impact between comparison and intervention (3·6 and 3·9, respectively). In particular, the consumption of pro-vitamin A-rich foods and other fruits and vegetables increased. No treatment effects on height-for-age Z-scores could be shown. NE led to improvements in children’s diets. For effects on growth, it is assumed that longer NE activities are required to achieve sustainable behaviour change of age-appropriate infant feeding.

International recommendations advise against the use of intravenous rehydration therapy in children with severe acute malnutrition because of the concern about fluid overload, but evidence to support this concern is lacking. Given the high mortality associated with the current recommendations, the adoption of intravenous rehydration strategies might improve outcomes. We conducted a factorial, open-label superiority trial in four countries in Africa. Children 6 months to 12 years of age with severe acute malnutrition with gastroenteritis and dehydration underwent randomization in a 2:1:1 ratio to one of three rehydration strategies: oral rehydration, plus intravenous boluses for shock; a rapid intravenous strategy that consisted of lactated Ringer's solution (100 ml per kilogram of body weight) administered over a period of 3 to 6 hours, with boluses for shock; or a slow intravenous strategy that consisted of the same solution administered over a period of 8 hours, with no boluses. The primary end point was death at 96 hours. A total of 272 children underwent randomization; 138 were assigned to the oral strategy, 67 to the rapid intravenous strategy, and 67 to the slow intravenous strategy. Participants were followed for 28 days. A nasogastric tube was used for oral rehydration in 126 of 135 participants (93%) in the oral group and in 82 of 126 (65%) in the intravenous groups. Intravenous boluses were administered at admission in 12 participants (9%) in the oral group, 7 (10%) in the rapid intravenous group, and none in the slow intravenous group. At 96 hours, 11 participants (8%) in the oral group and 9 (7%) in the intravenous groups (5 in the rapid group and 4 in the slow group) had died (risk ratio, 1.02; 95% confidence interval [CI], 0.41 to 2.52; P = 0.69). At 28 days, 17 participants (12%) in the oral group and 14 (10%) in the intravenous groups had died (hazard ratio, 0.85; 95% CI, 0.41 to 1.78). Serious adverse events occurred in 32 participants (23%) in the oral group, 14 (21%) in the rapid intravenous group, and 10 (15%) in the slow intravenous group. No evidence of pulmonary edema, heart failure, or fluid overload was noted. Among children with severe acute malnutrition and gastroenteritis, no evidence of a difference in mortality at 96 hours was noted between oral and intravenous rehydration strategies. (Funded by the Joint Global Health Trials scheme and others; GASTROSAM Current Controlled Trials number, ISRCTN76149273.).

Background: the aim of this study is to evaluate the effectiveness and coverage of a simplified protocol that is implemented in health centers (HCs) and health posts (HPs) for children who are suffering from severe acute malnutrition (SAM) in the humanitarian context of Diffa. Methods: We conducted a non-randomized community-controlled trial. The control group received outpatient treatment for SAM, without medical complications, at HCs and HPs with the standard protocol of community management of acute malnutrition (CMAM). Meanwhile, with respect to the intervention group, the children with SAM received treatment at the HCs and HPs through a simplified protocol wherein the mid-upper arm circumference (MUAC) and the presence of edema were used as the admission criteria, and the children with SAM were administered doses of fixed ready-to-use therapeutic food (RUTF). Results: A total of 508 children, who were all under 5 years and had SAM, were admitted into the study. The cured proportion was 87.4% in the control group versus 96.6% in the intervention group (p value = 0.001). There was no difference between the groups in the length of stay, which was 35 days, but the intervention group used a lower quantity of RUTF—70 sachets versus 90 sachets, per child cured. Coverage increases were observed in both groups. Discussion: the simplified protocol used at the HCs and HPs did not result in worse recovery and resulted in fewer discharge errors compared to the standard protocol.

Ghrelin is an orexigenic hormone that stimulates food intake by hypothalamic actions. There is limited data on its circulating levels, pathophysiological role, and prognostic and therapeutic potential in disease-related malnutrition. We investigated via this secondary analysis of the randomized controlled Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) the association of admission ghrelin levels in terms of malnutrition phenotype, nutritional target achievement, and treatment response. The primary outcome was 30-day all-cause mortality. A total of 997 patients with available ghrelin measurements were included. We found an association between high ghrelin levels upon admission and malnutrition severity according to the Nutritional Risk Screening 2002 (NRS) and an inverse association between high ghrelin levels and nutritional intake. Patients with high ghrelin levels had a 1.4-fold greater chance of reaching nutritional targets during hospitalization compared to those with lower levels (adjusted OR 1.40 [95% CI 1.01–1.93], P = 0.045). High ghrelin levels were not associated with mortality, complications, or adverse events, and both high and low ghrelin groups showed a similar response to nutritional therapy. We observed an association between high ghrelin levels upon admission in patients with more severe malnutrition according to the NRS and its components. A hypothesis may be generated that the hormone’s orexigenic effect is impaired due to ghrelin resistance. However, under nutritional therapy, patients with high ghrelin levels were more likely to achieve nutritional targets. Ghrelin analogs during hospitalization may help facilitate beneficial nutritional intake in this vulnerable patient population. Nevertheless, future research should investigate where this resistance stems from and differentiate between active and total ghrelin, as this could influence efficacy. •Inverse association between high ghrelin levels and nutritional intake.•Potentially impaired orexigenic effect of ghrelin due to ghrelin resistance.•Patients with high ghrelin levels were more likely to achieve nutritional targets.•Ghrelin analogs may overcome presumed ghrelin resistance and initiate food intake. [Display omitted]