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Background Innovations for undernourished pregnant women that improve newborn survival and anthropometry are needed to achieve the Sustainable Development Goals 1 and 3. This study tested the hypothesis that a combination of a nutritious supplementary food and several proven chemotherapeutic interventions to control common infections would increase newborn weight and length in undernourished pregnant women. Methods and findings This was a prospective, randomized, controlled clinical effectiveness trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy in undernourished pregnant women in rural Sierra Leone. Women with a mid-upper arm circumference (MUAC) [less than or equal to]23.0 cm presenting for antenatal care at one of 43 government health clinics in Western Rural Area and Pujehun districts were eligible for participation. Standard of care included a blended corn/soy flour and intermittent preventive treatment for malaria in pregnancy (IPTp). The intervention replaced the blended flour with RUSF and added azithromycin and testing and treatment for vaginal dysbiosis. Since the study involved different foods and testing procedures for the intervention and control groups, no one except the authors conducting the data analyses were blinded. The primary outcome was birth length. Secondary outcomes included maternal weight gain, birth weight, and neonatal survival. Follow-up continued until 6 months postpartum. Modified intention to treat analyses was undertaken. Participants were enrolled and followed up from February 2017 until February 2020. Of the 1,489 women enrolled, 752 were allocated to the intervention and 737 to the standard of care. The median age of these women was 19.5 years, of which 42% were primigravid. Twenty-nine women receiving the intervention and 42 women receiving the standard of care were lost to follow-up before pregnancy outcomes were obtained. There were 687 singleton live births in the intervention group and 657 in the standard of care group. Newborns receiving the intervention were 0.3 cm longer (95% confidence interval (CI) 0.09 to 0.6; p = 0.007) and weighed 70 g more (95% CI 20 to 120; p = 0.005) than those receiving the standard of care. Those women receiving the intervention had greater weekly weight gain (mean difference 40 g; 95% CI 9.70 to 71.0, p = 0.010) than those receiving the standard of care. There were fewer neonatal deaths in the intervention (n = 13; 1.9%) than in the standard of care (n = 28; 4.3%) group (difference 2.4%; 95% CI 0.3 to 4.4), (HR 0.62 95% CI 0.41 to 0.94, p = 0.026). No differences in adverse events or symptoms between the groups was found, and no serious adverse events occurred. Key limitations of the study are lack of gestational age estimates and unblinded administration of the intervention. Conclusions In this study, we observed that the addition of RUSF, azithromycin, more frequent IPTp, and testing/treatment for vaginal dysbiosis in undernourished pregnant women resulted in modest improvements in anthropometric status of mother and child at birth, and a reduction in neonatal death. Implementation of this combined intervention in rural, equatorial Africa may well be an important, practical measure to reduce infant mortality in this context. Trial registration ClinicalTrials.gov NCT03079388., Author(s): David Taylor Hendrixson 1, Kristie Smith 1, Patrick Lasowski 1, Meghan Callaghan-Gillespie 1, Jacklyn Weber 1, Peggy Papathakis 2, Per Ole Iversen 3, Aminata Shamit Koroma 4, Mark J. [...]

Highlights from News & Views published this year. Highlights from News & Views published this year., Author Affiliations: Robots, hominins and superconductors: 10 remarkable papers from 2019 Credit: Sylvain Cherkaoui/Reuters [see PDF for image] A porter carries fish from a fishing boat to the beach at [...]

Background 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. Methods and findings 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 Conclusions 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). Trial registration The trial is registered at ISRCTN, trial number ISRCTN30393230., Author(s): Jeanette Bailey 1,2,*, Charles Opondo 3, Natasha Lelijveld 4, Bethany Marron 1, Pamela Onyo 5, Eunice N. Musyoki 6, Susan W. Adongo 6, Mark Manary 7, André Briend 8,9, [...]

Background Children with uncomplicated severe acute malnutrition (SAM) are treated at home with ready-to-use therapeutic foods (RUTFs). The current RUTF dose is prescribed according to the weight of the child to fulfil 100% of their nutritional needs until discharge. However, there is doubt concerning the dose, as it seems to be shared, resulting in suboptimal cost-efficiency of SAM treatment. We investigated the efficacy of a reduced RUTF dose in community-based treatment of uncomplicated SAM. Methods and findings We undertook a randomised trial testing the non-inferiority of weight gain velocity of children with SAM receiving (a) a standard RUTF dose for two weeks, followed by a reduced dose thereafter (reduced), compared with (b) a standard RUTF dose throughout the treatment (standard). A mean difference of 0.0 g/kg/day was expected, with a non-inferiority margin fixed at -0.5 g/kg/day. Linear and logistic mixed regression analyses were performed, with study site and team as random effects. Between October 2016 and July 2018, 801 children with uncomplicated SAM aged 6-59 months were enrolled from 10 community health centres in Burkina Faso. At admission, the mean age (± standard deviation [SD]) was 13.4 months (±8.7), 49% were male, and the mean weight was 6.2 kg (±1.3). The mean weight gain velocity from admission to discharge was 3.4 g/kg/day and did not differ between study arms ([DELTA] 0.0 g/kg/day; 95% CI -0.4 to 0.4; p = 0.92) confirming non-inferiority (p = 0.013). However, after two weeks, the weight gain velocity was significantly lower in the reduced dose with a mean of 2.3 g/kg/day compared with 2.7 g/kg/day in the standard dose ([DELTA] -0.4 g/kg/day; 95% CI -0.8 to -0.02; p = 0.041). The length of stay (LoS) was not different (p = 0.73) between groups with a median of 56 days (interquartile range [IQR] 35-91) in both arms. No differences were found between reduced and standard arm in recovery (52.7% and 55.4%; p = 0.45), referral (19.2% and 20.1%; p = 0.80), defaulter (12.2% and 8.5%; p = 0.088), non-response (12.7% and 12.5%; p = 0.95), and relapse (2.4% and 1.8%; p = 0.69) rates, respectively. However, the reduced RUTF dose had a small 0.2 mm/week (95% CI 0.04 to 0.4; p = 0.015) negative effect on height gain velocity with a mean height gain of 2.6 mm/week with reduced and 2.8 mm/week with standard RUTF dose. The impact was more pronounced in children under 12 months of age (interaction, p = 0.019) who gained 2.8 mm/week with reduced and 3.1 mm/week with standard dose ([DELTA] -0.4 mm/week; 95% CI -0.6 to -0.2; p < 0.001). Limitations include not blinding participants to the RUTF dose received and excluding all children with negative appetite test. The results are generalisable for relatively food secure contexts with a young SAM population. Conclusions Reducing the RUTF dose provided to children with SAM after two weeks of treatment did not reduce overall weight or mid-upper arm circumference (MUAC) gain velocity nor affect recovery or lengthen treatment time. However, it led to a small but significant negative effect on linear growth, especially among the youngest. The potential effect of reducing the RUTF dose in a routine program on treatment outcomes should be evaluated before scaling up. Trial registration ISRCTN registry ISRCTN50039021., Author(s): Suvi T. Kangas 1,2,*, Cécile Salpéteur 2, Victor Nikièma 3, Leisel Talley 4, Christian Ritz 1, Henrik Friis 1, André Briend 1,5, Pernille Kaestel 1 Introduction Worldwide, 19 million [...]

BACKGROUND/OBJECTIVES: Parenteral nutrition (PN) should be provided to the malnourished patient if enteral feeding is insufficient or unsafe. A nutrition support team (NST) may improve PN services. We compared the use and complications of hospital PN before and after the implementation of an NST. SUBJECTS/METHODS: All inpatients referred for PN outside of the intensive care unit and the intestinal failure unit were prospectively included from 2009 to 2012. The NST was introduced in 2010. Quality improvement methodology was applied. RESULTS: In 2009, a mean of 16 (limits of normal variation 4-28) patients were referred for PN each month. After introduction of the NST, this rose to 26 (10-42) referrals per month. The percentage of referrals where PN was not initiated increased from 5.3% in 2009 to 10.1% in 2012 (P = 0.03). This increase was restricted to teams that infrequently referred for PN, and enteral nutrition could replace PN in 31 of 51 patients (61%) as compared with 8 of 32 (25%) patients referred from teams that frequently referred for PN (P = 0.001). The frequency of PN started owing to an insufficient oral or enteral intake decreased from 11% to 3% (P = 0.01). The catheter-related bloodstream infection rate dropped from 6.7 to 0.7 episodes per 1000 catheter days (P < 0.001). CONCLUSIONS: Introduction of an NST increased both the total PN use and the percentage of referrals where enteral nutrition could replace PN. Medical specialty influenced the referral pattern and the likelihood that a referral resulted in PN being initiated. Safety of PN catheters improved significantly following NST introduction. European Journal of Clinical Nutrition (2014) 68, 1294-1299; doi: 10.1038/ejcn.2014.186; published online 24 September 2014, INTRODUCTION Malnutrition remains a major risk factor for in-hospital morbidity and mortality. (1,2) A stepwise algorithm can be applied to patients who do not meet their nutritional requirements, (3,4) and [...]